Identity
- Device Name
- AST Rapid Test Kit EUDAMED
- Model / Reference
- A11014002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973861683009 EUDAMED
- Basic UDI-DI
- B-06973861683009 EUDAMED
- EMDN Code
- W01010110 ASPARTATE AMINO-TRANSFERASE 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
Category: Total aspartate aminotransferase (AST) IVD, reagent
AST Rapid Test Kit by Anbio (Xiamen) Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Total aspartate aminotransferase (AST) IVD, reagent.
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- aminotransferase — C.P.M. COMPAGNIA PER LA MEDICINA S.R.L. · IVD General
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-06973861683009 | 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 1fa99c17-4bc2-48c8-aad0-317a023d7f3b 61 fields · synced Jul 30, 2026