In Vitro Diagnostics Regulation (IVDR). 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.
Medical Device Regulation (MDR) is a set of regulations that govern the clinical investigation, production and distribution of medical devices in Europe.
The certificates 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 | 39148 rev. 0 | 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 | 38952 rev. 0 | 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. | EU QUALITY MANAGEMENT SYSTEM CERTIFICATE 38952 |
| Phadia AB | Rapsgatan 7P PO. Box 6460 751 37 Uppsala Sweden | 38953 rev. 0 | 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 |
| Oxoid Limited | Wade Road Basingstoke, Hampshire, RG24 8PW United Kingdom | IVDR 742163 R000 | 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 | IVDR 7417817 R000 | 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 | G10 057902 002 Rev.00 | 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 |