GENERI BIOTECH s.r.o.
CZ-MF-000018857 · Czechia · Hradec Kralove
GENERI BIOTECH s.r.o. is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- gb GENETIC A1AT
- gb GENETIC APOB (R3500Q)
- gb GENETIC APOE
- gb GENETIC FRUCTO
- gb GENETIC HFE
- gb GENETIC HLA-B*27
- gb GENETIC LACTO
- gb PHARM CYP2C19
- gb PHARM DPYD
- gb PHARM TPMT
- gb PHARM Warfarin
Showing 12 of 21 declared devices.
Catalogue references include 3206-50, 3219-025, 3219-050, 3250-050, 3252-050, 3255-050.
European nomenclature codes declared: W0106010499, W0106010299, W0106010203, W0106010401, W0106010105, W0106030104.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 21 |
| Country of registration | Czechia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 21 |
|---|---|
| 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. GENERI BIOTECH s.r.o. was not found in either the U.S. or the Canadian register.