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IVDR (In Vitro Diagnostics Regulation). IVDR is the regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market.
MDR (Medical Device Regulation) is a set of regulations that govern the clinical investigation, production and distribution of medical devices in Europe.
The certifications of IVDR and MDR products are available below to view and download.
If you need additional assistance on IVDR or MDR certificates, please contact Corporate_Quality_Regulatory@thermofisher.com
| Legal Entity | Site Address | Certification | Expiration Date | Scope Statement | Document |
|---|---|---|---|---|---|
| Phadia AB | Rapsgatan 7P PO. Box 6460 751 37 Uppsala Sweden | (EU) 2017/746 | October 6, 2027 | In Vitro Diagnostic medical devices including reagents indended to be used for the confirmation/determination of allergies and asthma | EU QUALITY MANAGEMENT SYSTEM CERTIFICATE 39148 |
| Phadia AB | Rapsgatan 7P PO. Box 6460 751 37 Uppsala Sweden | (EU) 2017/746 | April 13, 2027 | In Vitro Diagnostic medical devices inlcuding reagents, calibrators, control materials and software, intended to be used for the confirmation/determination of allergies and asthma. | GMED 38952 Rev.2 |
| Phadia AB | Rapsgatan 7P PO. Box 6460 751 37 Uppsala Sweden | (EU) 2017/746 | April 13, 2027 | In Vitro Diagnostic medical devices including reagents, calibrators and control materials, intended to be used for the determination of physiological markers for autoimmune diseases | EU QUALITY MANAGEMENT SYSTEM CERTIFICATE 38953.1 |
| Oxoid Limited | Wade Road Basingstoke, Hampshire, RG24 8PW United Kingdom | (EU) 2017/746 | November 28, 2027 | In Vitro Diagnostic medical devices intended for the determination of antimicrobial agent susceptibility and/or the qualative identification of infectious agents. | EU QUALITY MANAGEMENT SYSTEM CERTIFICATE 742163 R000 |
| Oxoid Deutschland GmBH | Am Lippeglacis 4-8 Wesel 46483 Germany | (EU) 2017/746 | November 09, 2027 | Qualitative Selective media for the identification of bacterial infections. | EU QUALITY MANAGEMENT SYSTEM CERTIFICATE 741817 R000 |
| Thermo Electron LED GmbH Zweigniederlassung Osterode | Am Kalkberg, 37520 Osterode am Harz, Germany | (EU) 2017/745 | November 19, 2028 | Device Group: B99 – Haematology and Haemotransfusion devices. This centrifuge is intended for separation of blood into blood components using blood bags. The blood components are intended to be used for human blood transfusion. Clinical facilities and institutions are responsible for the process of human blood transfusion. This intended use is limited to the associated rotors and components. | TUV 713279377 |
| Microgenics Corporation | 46500 Kato Road Fremont, CA 94538 USA | (EU) 2017/746 | December 11, 2028 | Devices intended to be used for monitoring of levels of medicinal products, substances or biological components. Products of Class B and Class C. | EU QMS HX 1061883-1 |
| Nalge Nunc International Corporation, a part of Thermo Fisher Scientific Inc. | 75 Panorama Creek Drive Rochester, NY 14625 USA | (EU) 2017/746 | January 16, 2029 | Class A Sterile devices, IVR 0803 Sterile specimen receptacles. | BSI US-MF-000026915 |
| Remel Europe Limited | Remel House Clipper Boulevard West Crossways Dartford Kent DA2 6PT United Kingdom | (EU) 2017/746 | January 9, 2028 | Agglutination tests intended to be used to detect the presence of, or exposure to an infectious agent. | BSI GB-MF-000016733 |
| The Binding Site Group Ltd | 8 Calthorpe Road Edgbaston Birmingham B15 1QT United Kingdom | (EU) 2017/746 | May 3, 2028 | Class D, C and B devices. Class C devices: Immunochemistry (Immunology) devices for in vitro detection of proteins as an aid in diagnosis and monitoring of monoclonal gammopathies, inflammatory conditions, kidney disease and haematological malignancies. Class B devices: Immunochemistry (Immunology) devices intended to be used for screening, determination or monitoring of physiological markers. | BSI Single Registration Number Not Available |
| Thermo Fisher Scientific OY | Ratastie 2 FI-01620 Vantaa Finland | (EU) 2017/746 | January 31, 2028 | Devices intended to be used for screening, determination or monitoring of physiological markers. | EU HX 1070846-1 |
| Remel, Inc. | 12076 Santa Fe Trail Drive, Lenexa, Kansas 66215, USA | IVDR 747791 | August 6, 2028 | In vitro diagnostic qualitative enzymatic devices and in vitro diagnostic software devices intended to be used to grow / isolate / identify and handle infectious agents. | BSI IVDR 747791 R000 |