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One Step Oxycodone Rapid Test (Urine)
EUDAMEDClass IVD General (EU MDR)
Ref Strip,Cassette,Panel,CupModel OXY-101
Identity
- Trade Name
- One Step Oxycodone Rapid Test (Urine) EUDAMED
- Device Name
- One Step Oxycodone Rapid Test (Urine) EUDAMED
- Model / Reference
- OXY-101 EUDAMEDStrip,Cassette,Panel,Cup EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939663977739 EUDAMED
- Basic UDI-DI
- B-06939663977739 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
No
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
One Step Oxycodone Rapid Test (Urine) by Sejoy Biomedical 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-06939663977739 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sejoy Biomedical Co., Ltd.
- EUDAMED SRN
- CN-MF-000008447
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 33f3965b-28f0-4780-8d01-e5bf6be2e741 61 fields · synced Jul 24, 2026
- EUDAMED 33f3965b-28f0-4780-8d01-e5bf6be2e741-1 61 fields · synced Jun 10, 2026