Identity
- Device Name
- ALP Rapid Test Kit EUDAMED
- Model / Reference
- A11015002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973861683016 EUDAMED
- Basic UDI-DI
- B-06973861683016 EUDAMED
- EMDN Code
- W01010105 ALKALINE PHOSPHATASE - TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ALP Rapid Test Kit by Anbio (Xiamen) Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06973861683016 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Anbio (Xiamen) Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023936
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED e285d9dc-ba08-415b-b9cf-58b84bc24491 61 fields · synced Jun 20, 2026