Identity
- Trade Name
- LYSUN EUDAMED
- Device Name
- Cocaine(COC) Rapid Test (Urine) EUDAMED
- Model / Reference
- COC-U21(25PCS) EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697177120147496 EUDAMED
- Basic UDI-DI
- B-697177120147496 EUDAMED
- EMDN Code
- W0102160506 COCAINE + COCAINE METABOLITES - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Lysun by Hangzhou Lysun Biotechnology 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-697177120147496 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Lysun Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000010254
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 0a8715d1-7f3e-4ecd-b9a2-3d54a2d04397 61 fields · synced Jun 19, 2026