Multi-Drug Rapid Test 1-Step Cup (Urine)
by Newlink Biotech co., Ltd. EUDAMED
Active
Ref L11-DOA17F1
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-L11-DOA17F1UF | Date30 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
EU market availability
Available in 31 countries, as listed in EUDAMED:
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
Specification
- Model / Reference
- L11-DOA17F1
- Primary DI / UDI-DI
- D-L11-DOA17F1UF
- Basic UDI-DI
- B-L11-DOA17F1UF
- EMDN Code
- W0102160511 Multiple drugs of abuse/toxicology rt & poc
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000045176
- Authorised representative
- VidaQuick Biotech S.L. ES-AR-000048138
Other devices from Newlink Biotech co., Ltd.
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No