Identity
- Trade Name
- bigfish EUDAMED
- Device Name
- Disposable Sampling Swabs EUDAMED
- Model / Reference
- BFDS-NA01、BFDS-NA02 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975514360517 EUDAMED
- Basic UDI-DI
- 697551436BFNA001KM EUDAMED
- EMDN Code
- A1101,A1102 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
bigfish by Hangzhou Bigfish Bio-tech Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697551436BFNA001KM | Class I | 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 a9823be6-09e2-45fe-965a-7199832483d0 61 fields · synced Jun 18, 2026