GeneMind
by GeneMind Biosciences Co., Ltd. China EUDAMED
Ref L000106Model 96 tests/kit
EMDN W0106010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-06974968583568 | Date9 Jan 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Cystic Fibrosis Detection Kit (Sequencing Method)
- Model / Reference
- 96 tests/kit, L000106
- Primary DI / UDI-DI
- 06974968583568
- Basic UDI-DI
- B-06974968583568
- EMDN Code
- W0106010101 Cystic fibrosis
- Device Class
- Class IVD General
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000025785
- Authorised representative
- Medunion S.L. ES-AR-000019366
Other devices from GeneMind Biosciences Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 7dd5d81c-f6ce-4967-acfe-00e247ee6d8c