α-L-Fucosidase Kit (CNPF Method)
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-003128-00Model please see UDI-DI for details EMDN W01010199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number694490400043AFU********F3 | Date19 Oct 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- α-L-Fucosidase Kit (CNPF Method)、AFU Control
- Model / Reference
- please see UDI-DI for details, 105-003128-00
- Primary DI / UDI-DI
- 06944904034997
- Basic UDI-DI
- 694490400043AFU********F3
- EMDN Code
- W01010199 Enzymes - other
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED fa2d693e-b26c-45a8-be16-a922fc926d2c