Hain Lifescience GmbH
DE-MF-000008606 · Germany · Nehren
Hain Lifescience GmbH is registered in the European database on medical devices as a manufacturer, with 78 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- Analyzer GENERIC HBV VL 2.0 FCXT
- FluoroLyse VER 1.0
- FluoroType® Factor II VER 1.0
- FluoroType® HH H63D VER 1.0
- FluoroType® HSV VER 1.0
- FluoroType® MTB VER 1.0
- FluoroType® MTBDR VER 2.0
- FluoroType® MTHFR C677T VER 1.0
- GenoType ApoE VER 1.0
- GenoType MTBDRplus VER 2.0
- Liquefaction Set VER 1.0
- Reagent Set for DNA•STRIP Kits
Showing 12 of 78 declared devices.
Catalogue references include 1896574, 1901991, 51696, 60024, 60296, 61196.
European nomenclature codes declared: W0105010703, W0105900101, W02050182, W0106010116, W0106010199, W02050192.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 78 |
| 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 | 78 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | HAIN LIFESCIENCE GMBH |
North American profile: Canada only. Hain Lifescience GmbH holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
V70 079456 0011 | issued | 2030-01-27 |
V70 079456 0010 | issued | 2029-03-03 |