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One Step Multi-Drug Test Dip Card (Urine)
EUDAMEDClass B (EU MDR)
Ref GBDOA-134-019
Identity
- Trade Name
- One Step Multi-Drug Test Dip Card (Urine) EUDAMED
- Device Name
- One Step Multi-Drug Test Dip Card (Urine) EUDAMED
- Model / Reference
- GBDOA-134-019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950996026468 EUDAMED
- Basic UDI-DI
- 69509960GBDOA134019ZE EUDAMED
- EMDN Code
- W0102090199 DRUGS OF ABUSE - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Portugal 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
New Device
No
EUDAMED
One Step Multi-Drug Test Dip Card (Urine) by Zhejiang Orient Gene Biotech Co., Ltd — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69509960GBDOA134019ZE | Class B | 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 adbb9d15-322e-4a90-b603-d3d2da15b21c 61 fields · synced May 23, 2026