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The K2 One Step Synthetic Cannabis Test (colloidal gold method)
EUDAMEDClass IVD General (EU MDR)
Ref Strip,Cassette,Panel,Cup
Identity
- Trade Name
- The K2 One Step Synthetic Cannabis Test (colloidal gold method) EUDAMED
- Device Name
- The K2 One Step Synthetic Cannabis Test (colloidal gold method) EUDAMED
- Model / Reference
- Strip,Cassette,Panel,Cup EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939663977791 EUDAMED
- Basic UDI-DI
- B-06939663977791 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
The K2 One Step Synthetic Cannabis Test (colloidal gold method) by Sejoy Biomedical 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-06939663977791 | 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 cb9ffae3-cd04-48ad-9579-06602e4a145e 61 fields · synced Jun 18, 2026
- EUDAMED cb9ffae3-cd04-48ad-9579-06602e4a145e-1 61 fields · synced Jun 10, 2026