Bio-Gram Diagnostics GmbH
DE-MF-000032559 · Germany · Worms
Bio-Gram Diagnostics GmbH is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- ColorJet Nano
- Crystal-Violete JetDye-AF
- Etzel I
- FixOstar
- FixOstar - Hema
- Giemsa JetDye-AF
- JaClean
- JetBuffer pH 6.4
- JetBuffer pH 6.8
- MGG JetDye-AF Kit
- MGG JetDye-AF System Kit
- Safranin-FX JetDye-AF
Showing 12 of 22 declared devices.
Catalogue references include RG2209003, RG2209026, RG2209027, RG2209031, RG2209032, RG2211056.
European nomenclature codes declared: W0103010302, W0104010804, W01030199, W02069099, W01030705, W0104010899.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BIO-GRAM DIAGNOSTICS GMBH (DE) · FDA 3044854712 |
| Devices in EUDAMED | 22 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 22 |
|---|---|
| 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: United States only. Bio-Gram Diagnostics GmbH is registered in the United States but was not found in the Canadian register.