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GHB One Step Gamma-hydroxybutyrate Test
EUDAMEDClass IVD General (EU MDR)
Ref "GHB-A01a, GHB-A04a
Identity
- Trade Name
- GHB One Step Gamma-hydroxybutyrate Test EUDAMED
- Device Name
- GHB One Step Gamma-hydroxybutyrate Test EUDAMED
- Model / Reference
- "GHB-A01a, GHB-A04a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GHB-A01a6X EUDAMED
- Basic UDI-DI
- B-GHB-A01a6X EUDAMED
- EMDN Code
- W0102160599 DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER 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
GHB One Step Gamma-hydroxybutyrate Test by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-GHB-A01a6X | 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 a631f29f-3d62-4a35-85e1-e2f073cd8b7d 61 fields · synced Jun 19, 2026
- EUDAMED a631f29f-3d62-4a35-85e1-e2f073cd8b7d-1 61 fields · synced Jun 9, 2026