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Anbio
EUDAMEDClass A (EU MDR)
Ref AF-100Model AF-100, AF-100S, AF-100C, AF-1200
Identity
- Trade Name
- Anbio EUDAMED
- Device Name
- Immunofluorescence Analyzer EUDAMED
- Model / Reference
- AF-100, AF-100S, AF-100C, AF-1200 EUDAMEDAF-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973861681722 EUDAMED
- Basic UDI-DI
- 6973861681647FP 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Anbio by Anbio (Xiamen) Biotechnology 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 | 6973861681647FP | Class A | Active |
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Manufacturer
- Manufacturer
- Anbio (Xiamen) Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023936
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 66a3b7d2-7782-4257-a801-729a874f5736 61 fields · synced Jun 18, 2026