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bigfish
EUDAMEDClass A (EU MDR)
Ref N/AModel BFVTM-50A,BFVTM-50C,BFVTM-50E, BFVTM-50F,BFVTM-50G
Identity
- Trade Name
- bigfish EUDAMED
- Device Name
- Viral Transport Medium Kit EUDAMED
- Model / Reference
- BFVTM-50A,BFVTM-50C,BFVTM-50E, BFVTM-50F,BFVTM-50G EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975514360487 EUDAMED
- Basic UDI-DI
- 697551436BFVTM0019K EUDAMED
- EMDN Code
- W05020199 SAMPLES TRANSPORT, CONTAINERS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
bigfish by Hangzhou Bigfish Bio-tech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697551436BFVTM0019K | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bigfish Bio-tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000027212
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 203dbb8e-377a-44a8-8488-dd1fd44b6f57 61 fields · synced Jun 18, 2026
- EUDAMED 203dbb8e-377a-44a8-8488-dd1fd44b6f57-1 61 fields · synced Jun 10, 2026