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Gabapentin(GAB) Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref GAB-1011/GAB-1012/GAB-1014/GAB-7012/GAB-7014
Identity
- Trade Name
- Gabapentin(GAB) Rapid Test EUDAMED
- Device Name
- Gabapentin(GAB) Rapid Test EUDAMED
- Model / Reference
- GAB-1011/GAB-1012/GAB-1014/GAB-7012/GAB-7014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697424646GAB000BXLL EUDAMED
- Basic UDI-DI
- B-697424646GAB000BXLL EUDAMED
- EMDN Code
- W0102160599 DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Gabapentin(GAB) Rapid Test by Safecare Biotech (Hangzhou) 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-697424646GAB000BXLL | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Safecare Biotech (hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000019109
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED fe9c3b53-b92f-4b1a-9b6a-dac71fdbf827 61 fields · synced Jun 20, 2026