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Anbio Biotech
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref A606101Ref AF-100SModel AF-100, AF-100S, AF-100C, AF-1200Ref AF-1200
Identity
- Trade Name
- Anbio Biotech EUDAMEDAnbio EUDAMED
- Device Name
- COVID-19 Antigen-Schnelltest (kolloidales Gold) / Nasenabstrich EUDAMEDImmunofluorescence Analyzer EUDAMED
- Model / Reference
- A606101 EUDAMEDAF-100, AF-100S, AF-100C, AF-1200 EUDAMEDAF-100S EUDAMEDAF-1200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973861687687 EUDAMED06973861681739 EUDAMED06973861681715 EUDAMED
- Basic UDI-DI
- B-06973861687687 EUDAMED6973861681647FP EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMEDW02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass A EUDAMED
- Market of Registration
- Germany EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMEDEUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
New Device
No
EUDAMED
Anbio Biotech by Anbio (Xiamen) Biotechnology Co., Ltd. — Class IVD devices for self-testing — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06973861687687 | Class IVD devices for self-testing | Active |
| EUDAMED | European Union | CE/IVDD | B-06973861687687 | Class IVD devices for self-testing | 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 (3)
- EUDAMED c765d6b7-729e-4098-8738-67bad42ad0bc 61 fields · synced Jul 14, 2026
- EUDAMED 34352b10-d2f1-4b3e-bd1c-99b1b1a8ce70 61 fields · synced May 17, 2026
- EUDAMED 95184b85-dce7-46f8-b65c-4c2265ff7442 61 fields · synced May 18, 2026