Heck Hygiene GmbH
DE-MF-000005183 · Germany · Fuldabrück
Heck Hygiene GmbH is registered in the European database on medical devices as a manufacturer, with 44 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 38 |
|---|---|
| Class IIb | 6 |
Devices declared under this manufacturer
- STERIMat ID NEU
- STERIPro Quick NEU
- Ventides GF
- Ventisept F
- Ventisept M Plus
- Ventisept Pur
- Ventisept forte NF
- Ventisept pur wipes
- Ventisept wipes RTU honigmelone
- Ventisept wipes RTU pink grapefruit
- medichem ID Kombi
- medichem Schnelldesinfektion plus
Showing 12 of 44 declared devices.
Catalogue references include 104413N-1, 204422, 323005, 323050P, 323070H, 323090P.
European nomenclature codes declared: D0701, D0901, D010199, D0902.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 44 |
| 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 | 44 |
|---|---|
| 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. Heck Hygiene GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2397GB448260122 | supplemented | 2028-06-11 |