IMMUCOR Medizinische Diagnostik GmbH
DE-MF-000006494 · Germany · Dreieich
IMMUCOR Medizinische Diagnostik GmbH is registered in the European database on medical devices as a manufacturer, with 96 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- Galileo Diluent
- Galileo NEO
- NEO Iris
- immuClone (1) Anti-C IgM
- immuClone (1) Anti-E IgM
- immuClone (2) Anti-c Galileo IgM
- immuClone (2) Anti-c IgM
- immuClone Anti-S IgM
- immuClone Anti-s IgM
- immuClone® (2) Anti-e IgM
- immuClone® Anti-A IgM
- immuClone® Anti-B IgM
Showing 12 of 96 declared devices.
Catalogue references include 0006721, 0007315, 0007517, 0064598, 0064600, 0066014.
European nomenclature codes declared: W0103030202, W0103030501, W0103030102, W0103030201, W0202030185, W0202030102.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 96 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 96 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. IMMUCOR Medizinische Diagnostik GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IX 1191616-9 | supplemented | 2028-12-03 |
IX 1191616-8 | supplemented | 2028-11-28 |
IX 1191616-7 | supplemented | 2028-10-24 |
IX 1191616-6 | supplemented | 2028-09-27 |
IX 1191616-5 | supplemented | 2028-11-27 |
IX 1191616-4 | supplemented | 2028-12-05 |
IX 1191616-3 | supplemented | 2028-09-27 |
IX 1191616-2 | supplemented | 2028-09-12 |