Identity
- Trade Name
- LYSUN EUDAMED
- Device Name
- Tramadol(TRA) Rapid Test Device(Urine) EUDAMED
- Model / Reference
- TRA-U11（25PCS） EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69717712013828Y EUDAMED
- Basic UDI-DI
- B-69717712013828Y EUDAMED
- EMDN Code
- W0102160511 MULTIPLE DRUGS OF ABUSE/TOXICOLOGY 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 Unknown
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-69717712013828Y | Class IVD General | Unknown |
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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 f1e8c465-a6ed-4866-bba0-98a8d4f823c8 61 fields · synced Jun 18, 2026