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PGB One Step Pregabalin Test (Urine)
EUDAMEDClass IVD General (EU MDR)
Ref Strip,Cassette,Panel,Cup
Identity
- Trade Name
- PGB One Step Pregabalin Test (Urine) EUDAMED
- Device Name
- PGB One Step Pregabalin Test (Urine) EUDAMED
- Model / Reference
- Strip,Cassette,Panel,Cup EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939663977814 EUDAMED
- Basic UDI-DI
- B-06939663977814 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
PGB One Step Pregabalin 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-06939663977814 | 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 33449e79-02e4-4845-ae59-5973fb85300d 61 fields · synced Jun 19, 2026
- EUDAMED 33449e79-02e4-4845-ae59-5973fb85300d-1 61 fields · synced Jun 10, 2026