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SOMA One Step Carisoprodol Test
EUDAMEDClass IVD General (EU MDR)
Ref SOMA-A01a, SOMA-A01b
Identity
- Trade Name
- SOMA One Step Carisoprodol Test EUDAMED
- Device Name
- SOMA One Step Carisoprodol Test EUDAMED
- Model / Reference
- SOMA-A01a, SOMA-A01b EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SOMA-A01aFT EUDAMED
- Basic UDI-DI
- B-SOMA-A01aFT 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
SOMA One Step Carisoprodol Test by Hangzhou Aichek Medical Technology 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-SOMA-A01aFT | 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 (2)
- EUDAMED 680dc2e3-584a-46f7-8720-6e0a42b315a4 61 fields · synced Aug 4, 2026
- EUDAMED 680dc2e3-584a-46f7-8720-6e0a42b315a4-1 61 fields · synced Jun 10, 2026