Notified body 0318

Notified body 0318. Electronic address: juan. The Spanish Competent Authority and Notified Body 0318 expects to finalize it during the second semester of 2020. The Commission publishes a list of designated Product with CE mark, certified by Notified Body 0318 The availability of each reference for the sale is linked to the authorization of commercialization in the country of destination Balloon diameter [mm] Effective length 142 cm Balloon length [mm] 6 8 10 12 15 1. info@ivascular. Sep 25, 2021 · 2 Notified Body 0318, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain. As of 26 November 2017, conformity assessment bodies may submit an application for designation as a notified body under Regulation (EU) 2017/745 and Regulation (EU) 2017/746. It shall assign a single identification number even when the body is notified under several Union acts. Email us with corrections or additions. Centro Nacional Reviews & Capacity. 0318, based at the Spanish Medicines Agency (AEMPS), 2021; Visit us on. Commission Implementing Regulation 2017/2185 establishes the codes for the designation of notified bodies in medical devices under Regulation (EU) 2017/745 and in vitro diagnostic medical devices under Regulation (EU) 2017/746. Ar ticle 2 Application for designation Confor mity assessment bodies shall use the lists of codes and cor responding types of devices set out in Annexes I and II notified bodies under the Regulation (EU) 2017/745 (MDR) This draft list of codes has been created in the context of preparations of the future implementing act under Article 42(13) MDR. 2 For example, if the digits 0318 appear next to the CE mark on the label or the instructions for use of a medical product, it indicates that the evaluation was conducted by the National Certification Center for Medical Product, the sole notified . If the requirements are being fulfilled, the That is why Deltalab, recently renovated the CE Certificate, granted by the Notified Body No. 016” Crossing profile from 0. The term medical devices also includes in vitro diagnostics. EU Notified Bodies designated under the EU MDR (2017/745) Jul 14, 2022 · Notified Body number : 0318. 50 BCSR14150150006 BCSR14150150008 BCSR14150150010 BCSR14150150012 BCSR14150150015 EU Notified Bodies List : NB 0318 AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS. Help us keep this information up to date. 0 Abr 2021 Introducer compatibility: 6F Introducer compatibility: 7F Distributed by:. CNCPS - NOTIFIED BODY 0318 Date: 03/07/2024 Reference: SEC002_DEX03_20240703v2 NOTIFIED BODY CONFIRMATION LETTER SOCIEDAD ESPAÑOLA DE CARBUROS METÁLICOS S. CONTACTS. F. Via Quintiliano, 4320138 - MILANOCountry : Italy Notified Body number : 0051 CE 0066 ISTITUTO DI CERTIFICAZIONE EUROPEA PRODOTTI INDUSTRIALI S. Jun 20, 2019 · The Regulatory Affairs Professional Society (RAPS) is reporting that the Spanish Notified Body (NB) is winding down it certification of medical devices for compliance with the European Union’s (EU’s) Medical Device Directive (92/42/EEC, frequently referred to as the MDD), amplifying concerns about the certification resources available to demonstrate compliance with the EU’s Medical Notified Body Conformity Assessment including EMA coordination of Clinical Evaluation Consultation Procedure (CECP) and Performance Evaluation Consultation Procedure (PECP) Industry Standing Group (ISG) meeting, 21 June 2022 Presented by Alexey Shiryaev, Sabina Hoekstra - Team-NB Silvy da Rocha Dias, Miguel Antunes - EMA Jan 2, 2018 · TEAM-NB published its Notified Bodies members’ intention to submit an application to be designated against MDR and/or IVDR. Email: service •The MDR foresees the existence of public notified bodies: AEMPS NB 0318 Activities related to certification of QMS and NB are carried out by the AEMPS certification area (ENAC accreditation) •To reinforce independence a new administrative situation is in process… •Current scenario: OSCANN is a diagnosis plataform that combines the analyisis of ocular and oculocephalic movements (OM/OCM) with data obtained from other sources (clinical histories, medical explorations, complementary trials and biomarkers) that will help the physician to improve significantly the quality of medical assessments in early stages for many neurological and mental disorders. Camí de Can Ubach, 11 (Pol. Declining new customers. 3 Department of Pharmaceutics and Food Technology, Faculty of Pharmacy, Complutense University of Madrid, Madrid, Spain; Institute of Industrial Pharmacy, Complutense University of Madrid, Madrid, Spain. ID number Notified Body Country 0086 BSI Product Certification UK 0124 DEKRA Certification […] > Over-the-wire catheter (OTW) > Usable catheter length: 100 cm. Ş. 3 Notified Body 0318 Cuadro de Reducción Simple Team-NB welcomed a 25th member, namely AEMPS - Spain Notified Body (NB) designated against Regulation (EU) 2017/745 (MDR) and identified by the number 0318 on NANDO, has received a formal application in accordance with Section 4. of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the Notified Body and UK Approved Body lead times BSI is a full scope Notified Body and UK Approved Body and can accept and certify all types of medical devices and in-vitro diagnostic medical devices (IVDs). The rest of pathogens have the self-certified CE marking. Below, an extract from NANDO, where conditions/limitations are listed: MDA 0201 Active non-implantable imaging devices utilising ionizing radiation. 018” (0. 3, second subparagraph of Annex VII of Information about bodies including their contact and notification details can be found in section Notified bodies. Depending on the risks associated with a medical device, an independent notified body has to be involved to check and/or test whether these legal requirements are fulfilled. 0318, based at the Spanish Medicines Agency (AEMPS Julia Caro is the Head of Service of the Certification Area at the Spanish Agency of Medicines and Medical Devices (AEMPS) where she has been working as an auditor and product reviewer since 2016. global Reach & dilate Conic atraumatic tip design for most severe lesions Optimum deflation Enhanced dual Product with CE mark, certified by Notified Body 0318 Life Vascular Devices Biotech, S. Thread starter marie luis murray; Start date Mar 29, 2021; M. MDA 0318 Other active non-implantable devices; MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices; COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185. Spain NB 0321 SATRA. L www. Search by country; Search by legislation; Free search; The lists of notified bodies are given for information only and are valid at the date indicated. The MDR extension is sure going to help. 0318 in the following medical devices, valid until 06/10/2020: Swab, Specimen collecting. 8 mm: 14 atm) > ABP: 20 atm Product with CE mark, certified by Notified Body 0318 100 cm 0 Introducer compatibility: 4F 0 Introducer bottom. 485 and “CE of Notified Body” 0318, among others. Via Paolo Belizzi, 29/3329122 - PIACENZA (PC)Country : Italy Notified Body number : 0066 Check Nando status about the current notified bodies designated for MDR certification Additional useful links List of accreditation body List of Notified bodies per Applied-for scope of designation and notification of a Conformity Assessment Body – Regulation (EU) 2017/745 (MDR)1 Name of the national authority responsible for notified bodies (DA) Name of the applicant conformity assessment body (CAB) and, if applicable, notified body's identification number2 Address of the CAB Date of application Consult iVascular's entire angiolite catalogue on MedicalExpo. org Join thousands of precision medicine and life science innovators at the 32nd International Precision Med Tri-Conference & Expo, March 11-13, 2025, Hilton San Diego Bay Front in San Diego, CA. In a way, the Notified Body act as a gatekeeper to the EU market – for more ‘high-risk’ and ‘sensitive’ products that cannot be ‘self-certified’. If any active device does not fit in any code, which is listed above MDA 0318 “Other active non-implantable devices”, then the code of the device is determined as MDA 0318. Product with CE mark, certified by Notified Body 0318 Rapid Exchange catheter (RX) Compatible with 0. S. Istituto Superiore di Sanità . Limited to x-ray medical devices, gamma cameras and positron emission tomography Information about bodies including their contact and notification details can be found in section Notified bodies. marie luis murray Finally the Spanish NB 0318 has received the notification. NSAI Legal Metrology are a Notified Body (0709) for the Non-automatic Weighing Instrument Directive (2914/31/EU) and the Measuring Instrument Directive (2014/32/EU). de la Fama, 1 08940 Cornellà de Llobregat - Barcelona NOTIFIED BODY CONFIRMATION LETTER REFERENCE: SEC002_DEX03_20240703v2 To whom it may concern, Product with CE mark, certified by Notified Body 0318 References MCC C14 135 001 MCC C14 150 001 Usable length 135 cm Usable length 150 cm The availability of each reference for the sale is linked to the authorization of commercialization in the country of destination Outstanding trackability through the small and tortuous arteries due to *The Notified Body 0318 is only involved in the identification of Chlamydophila pneumoniae. The name of the organization behind that number can be found on the European Commission’s website. Last update: June 2024 Notified Body and UK Approved Body lead times Quality Management System (QMS) audits and microbiology audits *El Organismo Notificado 0318 solo interviene en la identificación de Chlamydia Trachomatis incluida en 7041S035A/7042S035A. Details about the newly designated NB: Jan 20, 2023 · The NANDO database has a new Notified Body under the MDR! SLG PRÜF UND ZERTIFIZIERUNGS GMBH is the 37th EU Notified Body under the Regulation (EU) 2017/745 on medical devices – MDR: SLG PRÜF UND ZERTIFIZIERUNGS GMBH Burgstädter Strasse 20 09232 Hartmannsdorf Country: Germany. In the case of the Spanish Notified Body CNCPS 0318, this is the information: There is no reviewer and they state that they do not admit new clients? not true. These codes are primarily used by designating authorities to define May 13, 2022 · The Notified Body 0318 (AEMPS) has issued the certification about the Certest Biotec Rapid Test for the qualitative detection of the SARS-CoV-2 virus antigen is enabled for self-testing use. virtumed. You can find the full scope of its notification on the following link. global The availability of each reference for the sale is linked to the authorization of commercialization in the country of destination > Triple sheath catheter > Catheter length: 80 and 140 cm > Compatible ujith 6F introducers > Compatible with 8F guiding catheters > Compatible ujith 0,035” guideujires > 4 RO markers in each end of the stent > 3 RO markers in the catheter > 2 handle sizes: • Small (L: 40 mm -100 mm) • Large (L: > 100 mm) Product uuith CE mark, certified by Notified Body 0318 5 SPN BC35 080 050 040 Our long-standing commitment to excellence has established us as an industry standard, backed by the most important international certifications: ISO 13. mechanical integrity Fast deflation Trilayer balloon Advanced crimping technology 1 Proprietary hydrophilic coating with long lasting durability PEBAX: anti-dislodgement Soft layer for cushion effect NYLON: anti-puncture Reinforced inner layers Open cell design Outstanding radial force Alternate spiral links Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the A Belgian authority responsible for the notification of bodies under a "new approach" directive must provide the following information: the regulation concerned; the name of the body and, where appropriate, its abbreviated name; the body's postal address; the body's telephone and fax numbers; the body's electronic address; the body's website May 14, 2024 · The NANDO database now includes the first Austrian MDR Notified Body, which brings the total number of notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) to 49. A Av. 019” max. 299, Viale Regina Elena, 00161 – Roma (Italy) VAT No. notified bodies in the field of in vitro diagnostic medical devices under Regulation (EU) 2017/746 is set out in Annex II to this Regulation. Jul 9, 2019 · Last week, the Spanish Agency of Medicines and Medical Products (AEMPS) announced it’s notified body (NB) 0318 has begun the process to become designated as NB under the European Union’s medical device regulation (MDR). The same logic also applies for non-active non-implantable devices, in that case the code is MDN 1214 “General non-active non-implantable devices used in Notified Body Hidden. Background to notified bodies and differences to pharma regulatory system. To be designated, a candidate organisation must fulfil specific requirements on organisational aspects, quality management, resources and processes verified by national authorities responsible for notified bodies with the involvement of other European experts. L. NL 0124 DEKRA Certification GmbH DE 2460 DNV NO 0297 DQS Medizinprodukte DE 0653 EKAPTY SA GR 1282 Ente Certificazione Macchine IT 0477 Eurofins IT 0459 GMED FR 2803 HTCert CY Product with CE mark, certified by Notified Body 0318 The availability of each reference for the sale is linked to the authorization of commercialization in the country of destination Balloon diameter [mm] Effective length 142 cm Balloon length [mm] 6 8 10 12 15 1. Mar 29, 2021 · Spain Notified Body. 051” 2 radiopaque markers (Pt-Ir) Balloon material: Nylon and Pebax Semi-compliant balloon Mean deflation time: 3s Product with CE mark, certified by Notified Body 0318 Kissing balloon technique 6F compatible he lo tansition pofile eteen the hypote and the distal shaft allos issin alloon technie The availability of each reference for the sale is linked to the authorization of commercialization in the country of destination Key Features www. 014” guidewire Compatible with 5F guiding catheter Tip profile: 0. A. www. The assessments also take into account the horizontal Act on notified bodies, 278/2016 , and the national act on the industry. IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S. Declining new customers (updated 10/2022) Centro Nacional Reviews. B. 2 y 4. The document indicates that 13 TEAM-NB members (see list below) have expressed their intention to apply to become Notified Bodies (NB) under the IVD Regulation 2017/746. 03657731000 C. Les Fallulles) 08620 Sant Vicenç dels Horts Barcelona +34 936 724 711. global The availability of each reference for the sale is linked to the authorization of commercialization in the country of destination Product with CE mark, certified by Notified Body 0318 MP51271 Ed. 10:15 Quality Management System: General review of the Quality Management of Medical Devices (MD/IVD) companies. HU 1912 Kiwa Dare Services NL 0344 DEKRA Certification B. The Commission shall assign an identification number to each notified body for which the notification becomes valid in accordance with Article 42(11). Nov 30, 2021 · In May 2021, the Medical Device Regulation (MDR) officially replaced the Medical Device Directive (MDD) with the aim to enhance safety for European patients through a more robust and transparent framework. EN 0318** ES PCR en tiempo real para la detección cualitativa y diferenciación de Mar 29, 2021 · Notified Body Spain. Last tried 10/2022. Furthermore, this guide is intended to bring consistency and to align the working practices Notified Bodies. The designation Jan 25, 2022 · *The Notified Body 0318 only intervenes in the evaluation of the compliance of the test for Chlamydia trachomatis Biovars A-K in urine and semen samples; urethral, endocervical and anal swabs. Page: 1/4. is overall the 48th EU Notified Body notified under Regulation (EU) 2017/745 on medical devices – MDR. Caro-Barri Julia Slides, Notified Body No. May 4, 2020 · Further for the IVDR, the number of Notified Bodies for IVDs is reflecting a similar lag from 39 original IVDD notified bodies to 3 IVDR certified bodies. Ind. Notified Body 0318 Conectores para Tomas CM de gases medicinales 8420219CGMBP Class IIb N/A CE Certificate nº 2013 07 0802 CT Epigraph 5. The lists include the identification number of each notified body as well as the tasks for which it has been notified, and are subject to regular update. Market surveillance (ICSMS) Information and Communication System for Market Surveillance (ICSMS) is the comprehensive communication platform for market surveillance on non-food products and for mutual recognition for goods. 80211730587 Phone: +39 06 4990 1 Product with CE mark, certified by Notified Body 0318 Balloon length (mm) Balloon Usable catheter length: 142 cm diameter (mm) 10 15 20 25 30 40 BC PR14N 150 125 010 Oct 14, 2021 · 9:30 Changes of the entry into force of the new IVDR Regulation. Auditor/Reviewer of AEMPS Certification area – Notified Body 0318 19 october 2021. oceanus 35 PTA balloon dilatation catheter www. Jun 3, 2022 · Notified Body number: 0633. Intertek Medical Notified Body ABTorshamnsgatan 43, Box 1103SE-164 22 KistaCountry : Sweden Notified Body number : 2862 A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. Picture: SARS-CoV-2 simple test for self-testing. es. Jul 10, 2019 · Article 43 Identification number and list of notified bodies 1. ivascular. 0318, based at the Spanish Medicines Agency (AEMPS), 2021 Julia Caro. aparicio. CE 0318. 3, first subparagraph of Annex VII of MDR and has signed a written agreement in accordance with Section 4. blanco@ucm. global Jul 3, 2023 · Nice to see you here, interesting initiative but based on the surveys of 56 anonymous customers and does not have updated or the number of Notified Bodies no comments. Product with CE mark, certified by Notified Body 0318 features iVolution triple sheath catheter Catheter length: 80 and 140 cm Compatible with 6F introducers Compatible with 8F guiding catheters Compatible with 0,035” guidewires 4 RO markers in each end of the stent 3 RO markers in the catheter 2 handle sizes: Small (L: 40 mm - 100 mm) Large Product with CE mark, certified by Notified Body 0318 Balloon length (mm) Balloon Usable catheter length: 142 cm diameter (mm) 10 15 20 25 30 40 BC PR14N 150 125 010 Product with CE mark, certified by Notified Body 0318 The availability of each reference for the sale is linked to the authorization of commercialization in the country of destination Created Date Legal Metrology - Notified Body 0709 under the MID and NAWI Directive. 029” up to 0. Invasive sterile collection system by direct contact with the patient. IUo-049 Ed00 0222 -81 Rev00 Page 2F09 of 28 Uso previsto According to this, a notified body can be an accredited testing laboratory, an inspection body or a certification body. 140 cm or 150 cm > Recommended guidewire: 0. Notified Body - Medical Device CE Marking. United Kingdom NB 0326 The Notified body finder tool will give you up-to-date basic information about the relevant notified bodies, such as their contact details and in some cases even their price list. EFCI Register, part of Stichting EMCI Register (NANDO 2832) is a Notified Body for the Fertilising Products Regulation 2019/1009. Although it transpired that this might not necessarily be the case[2], it raised the question of who would be impacted by a development such as this? Durante el proceso de designación conforme al MDR, el Organismo Notificado 0318 ha demostrado disponer de competencia y capacidad para ser designado para una amplia variedad de tipos de productos sanitarios, con un total de 54 códigos: 29 de ellos corresponden a códigos de finalidad (MDA, MDN) y otros 25 a códigos horizontales (MDT, MDS). The document has not been adopted or endorsed by the European Commission, and any views expressed reflect the Notified Body No. 50 BCSR14150150006 BCSR14150150008 BCSR14150150010 BCSR14150150012 BCSR14150150015 Product with CE mark, certified by Notified Body 0318 Life Vascular Devices Biotech, S. Centro Nacional Capacity. 014'' compatible) > Tip profile: 0. P. Jan 12, 2024 · Shown below is a list of European Notified Bodies that have been designated under the EU MDR or IVDR. Jun 4, 2019 · It was recently reported that Spain’s sole Notified Body (NB 0318) was no longer intending to certify under EU MDR. May 10, 2024 · The NANDO database lists a new Notified Body under the MDR, which is the second NB in 2 days! Kiwa Belgelendirme Hizmetleri A. Chaussée de Vilvorde, 1561120 BRUXELLESCountry : Belgium Notified Body number : 0029 Product with CE mark, certified by Notified Body 0318 Life Vascular Devices Biotech, S. Number Notified Body Country 0318 AEMPS SP 2797 BSI NL 2409 CE Certiso Kft. Notified body involvement on quality, safety and performance of delivery devices. Phone: +49:3722:7323-0 Fax: +49:3722:7323-899. Speaker: Gloria Hernández, Director of Notified Body 0318 (AEMPS). Information about bodies including their contact and notification details can be found in section Notified bodies. A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. global info@ivascular. 057” > Nominal pressure: 7 atm > RBP: 16 atm (diam. *The Notified Body 0318 is only involved in the identification of Chlamydia Trachomatis included in 7041S035A/7042S035A. As Notified Bodies are officially designated, we will add them here. Information related to Notified Bodies. > Crossing profile: from 0. 2 Notified Body 0318 Cuadro de Corte de Zona de Gases Medicinales 8420219CCZC5 Class IIb N/A CE Certificate nº 2013 07 0802 CT Epigraph 4. To date, for both IVD and Medical Device Notified Bodies, about 10% of them have made the cut to certification under the new regulations. Manufactured by: Life Vascular Devices Biotech, S. Summary MDR codes coverage More than 80% of codes are covered by more than 20/36 NBs Just 5 codes are covered by less than 1/3 NBs: ─MDA 0102:Active implantable devices delivering Information about bodies including their contact and notification details can be found in section Notified bodies. 043” to 0. If they are successfully designated in […] the notified body scope of designation but they are also used by the notified body to: 1) describe the individual qualification of the NBs staff members 2) describe the qualification required for assessing a device These codes may be very broad and, furthermore, unequivocal authorisation of personnel to codes Information about bodies including their contact and notification details can be found in section Notified bodies. We can provide Module B CE certification for your fertilising products as well as our expertise in the fertilising sector. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation such as Pressure Equipment Directive (PED), when a third party is required. CE: 2005 06 0474 CP Product with CE mark, certified by Notified Body 0318 MP51271 Ed. V. Requirements and guidelines (updated 13th of November 2020) The accreditation requirement for A manufacturer is only allowed to market a medical device in Europe if it fulfils certain legal requirements. global Applied-for scope of designation and notification of a Conformity Assessment Body – Regulation (EU) 2017/745 (MDR)1 Name of the national authority responsible for notified bodies (DA) Name of the applicant conformity assessment body (CAB) and, if applicable, notified body's identification number2 Address of the CAB Date of application Vertigo Inspection (ROI) Ltd t/a Irish Engineering ServicesRSA House, Dundrum Town Centre, Sandyford Road, Dublin 16 D16 FC92DublinCountry : Ireland Notified Body number : 2820 CE 2831 BRE Global Assurance (Ireland) LtdDCU Alpha, Old Finglas Road, GlasnevinDublin 11 D11 KXN4Country : Ireland Notified Body number : 2831 Jul 18, 2019 · AEMPS initiates the process towards becoming an MDR Notified Body. Reviews of Centro Nacional, a Notified Body in Spain. global The availability of each reference for the sale is linked to the authorization of commercialization in the country of destination TÜV AUSTRIA SERVICES GMBHDeutschstraße 101230 WIENCountry : Austria Notified Body number : 0408 CE 0433 ÖSTERREICHISCHE VEREINIGUNG FÜR DAS GAS- UND WASSERFACHSchubertring, 141015 WienCountry : Austria Notified Body number : 0433 the notified body scope of designation but they are also used by the notified body to: 1) describe the individual qualification of the NBs staff members 2) describe the qualification required for assessing a device These codes may be very broad and, furthermore, unequivocal authorisation of personnel to codes Designation of a notified body. 1111 Exposition Blvd, Building 100 May 13, 2022 · The Notified Body 0318 (AEMPS) has issued the certification about the Certest Biotec Rapid Test for the qualitative detection of the SARS-CoV-2 virus antigen is enabled for self-testing use. The link you will get will be in future constantly updated in the case of the designation of new notified bodies that will be entered into the NANDO database. APRAGAZ A. global Dec 14, 2020 · The role of a Notified Body is to assess if a product is technically safe and compliant, correctly documented, and (in some cases) manufactured under the right conditions. Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the Id. I have read the document INFORMATION AND CONDITIONS FOR CERTIFICATION AND CE MARK BY NOTIFIED BODY 0318, understands the requested certification procedure and ORGANISMO NOTIFICADO 0318 Página 9 de 19 MINISTERIO DE SANIDAD, SERVICIOS SOCIALES E IGUALDAD Agencia Española de Medicamentos y Productos Sanitarios accepted conditions conducting designation assessments of conformity assessments bodies (CABs) that apply for designation as a notified body in the field of medical devices and/or in vitro diagnostic medical devices. qxcb dkeyfp sbrbqt clsi fmrofn gqrwg qcatep gwpaj kuyj ezx