Immundiagnostik AG
DE-MF-000020905 · Germany · Bensheim
Immundiagnostik AG is registered in the European database on medical devices as a manufacturer, with 476 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- Coenzym Q10 HPLC Kit
- DNA-Stabilisator
- IDK® FABP2 ELISA
- IDK® Zonulin ELISA
- MutaPLATE® Faktor II (TM)
- MutaPLEX® Babesia, PCR
- MutaPLEX® EU/BAC/BIF, PCR
- MutaPLEX® Enterovirus, PCR
- MutaPLEX® FSME, PCR
- MutaPLEX® GBS (Group B Streptococci), PCR
- MutaPlex Borrelia/Rickettsia, PCR
- MutaREAL® UGT1A1
Showing 12 of 476 declared devices.
Catalogue references include K 6809, KC1700, KF1901632, KF291896, KG191096, KG192432.
European nomenclature codes declared: W0106010499, W0102019099, A99, W05019001, W0201050201, W0102019009.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | IMMUNDIAGNOSTIK AG (DE) · FDA 3005452690 |
| Devices in EUDAMED | 476 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 476 |
|---|---|
| Found in the U.S. device database | 8 |
| Share | 1.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | IMMUNDIAGNOSTIK AG |
North American profile: Both markets. Immundiagnostik AG is registered in both the United States and Canada.