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One Step Drugs of Abuse Test Strip (Urine)
EUDAMEDClass IVD General (EU MDR)
Ref GBXXX-101
Identity
- Trade Name
- One Step Drugs of Abuse Test Strip (Urine) EUDAMED
- Device Name
- One Step Drugs of Abuse Test Strip (Urine) EUDAMED
- Model / Reference
- GBXXX-101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GBXXX-101ND EUDAMED
- Basic UDI-DI
- B-GBXXX-101ND EUDAMED
- EMDN Code
- W0102090199 DRUGS OF ABUSE - 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
One Step Drugs of Abuse Test Strip (Urine) by Zhejiang Orient Gene Biotech 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-GBXXX-101ND | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 49832d14-2013-4cd3-bdd0-b36c2568941b 61 fields · synced Jun 18, 2026