EUROIMMUN Medizinische Labordiagnostika AG
DE-MF-000005296 · Germany · Lübeck
EUROIMMUN Medizinische Labordiagnostika AG is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: AF 101-R, EI 2771 G, EI 2771 M, FA 1128-1-R, FA 1156-50-R.
Devices declared under this manufacturer
- ANA (HEp-2) IIFT
- ANA (HEp-20-10) IIFT
- Anti-MOG IIFT
- Anti-Oropouche Virus ELISA (IgG)
- Anti-Oropouche Virus ELISA (IgM)
- EUROMicroblot Anti-Borrelia (IgG)
- FITC-labelled anti-human IgA
- Incubation plate set for UNIQO 400
- NMOSD Mosaic 1 IIFT
- Sample Buffer for Anti-AChR ELISA (IgG)
- TITERPLANE reagent tray for EUROArray slides
Showing 12 of 20 declared devices.
Catalogue references include AF 101-0546-R, EI 2771-9601 G, EI 2771-9601 M, FA 1128-2005-1-R, FA 1128-2010-1-R, FA 1520-1050-R.
European nomenclature codes declared: W0102100101, W0102109099, W0105040699, W01029099, W0105010603, W05039099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG (DE) · FDA 3003268355 |
| Devices in EUDAMED | 20 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 20 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 10.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG |
What it holds in Canada
| Licences on record | 205 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 181 |
| Class 3 devices | 24 |
| First licensed | 2004-05-31 |
Licence types: Test Kit (189), Single Device (11), System (2), Device Family (2).
Licensed under: IIFT MOSAIC: BASIC PROFILE 2 EUROPATTERN, IIFT: NMOSD SCREEN 1 EUROPATTERN, IIFT: CRITHIDIA LUCILIAE SENSITIVE (ANTI-DSDNA, IIFT: AUTOIMMUNE ENCEPHALITIS MOSAIC 6 EUROPAT, EUROLABWORKSTATION ELISA, EUROLABWORKSTATION IFA.
North American profile: Both markets. EUROIMMUN Medizinische Labordiagnostika AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 1483000-1 | supplemented | 2028-05-09 |