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Multi-Drug Test Panel (AMP +4 more)
EUDAMEDClass IVD General (EU MDR)
Ref DOA-A54-014
Identity
- Trade Name
- Multi-Drug Test Panel (AMP/COC/MET/MOP/THC) EUDAMED
- Device Name
- Multi-Drug Test Panel (AMP/COC/MET/MOP/THC) EUDAMED
- Model / Reference
- DOA-A54-014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DOA-A54-0146B EUDAMED
- Basic UDI-DI
- B-DOA-A54-0146B EUDAMED
- EMDN Code
- W0102160511 MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Multi-Drug Test Panel (AMP +4 more) by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — 5 models
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-DOA-A54-0146B | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 70bf494b-ca9d-4732-8cea-d0ae2244b7bf 61 fields · synced Jul 26, 2026