Identity
- Trade Name
- bigfish EUDAMED
- Device Name
- Automatic Nucleic Acid Purification Instrument EUDAMED
- Model / Reference
- BFEX-16、BFEX-32、BFEX-96、BFEX-96E EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975514360114 EUDAMED
- Basic UDI-DI
- 697551436BFEX001MK EUDAMED
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
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 | 697551436BFEX001MK | 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 (1)
- EUDAMED d5816d37-023e-4447-b796-fb1cbbd28aa5 61 fields · synced Jun 18, 2026