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Anbio Biotechnology
EUDAMEDClass A (EU MDR)
Ref AF-100Model AF-100, AF-100S, AF-100C, AF-1200
Identity
- Trade Name
- Anbio Biotechnology EUDAMED
- Device Name
- Immunofluorescence Analyzer EUDAMED
- Model / Reference
- AF-100, AF-100S, AF-100C, AF-1200 EUDAMEDAF-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973861682552 EUDAMED
- Basic UDI-DI
- 6973861682552FJ EUDAMED
- EMDN Code
- W02010299 IMMUNOCHEMISTRY INSTRUMENTS - 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
Anbio Biotechnology by Anbio Biotechnology Limited — 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 | 6973861682552FJ | Class A | Active |
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Manufacturer
- Manufacturer
- Anbio Biotechnology Limited
- EUDAMED SRN
- CN-MF-000042849
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED dcc94890-30a8-4b6b-a9b4-8853213325e4 61 fields · synced Jun 19, 2026