MAGLUMI ANA Screen (CLIA)
by Shenzhen New Industries Biomedical Engineering Co., Ltd. EUDAMED
Active
Ref 130617503M
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69471455405W5 | Date21 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- ANA Screen (CLIA)
- Model / Reference
- 130617503M
- Primary DI / UDI-DI
- 06947145517014
- Basic UDI-DI
- 69471455405W5
- EMDN Code
- W0102100101 Ana screening
- Device Class
- Class B
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000005655
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen New Industries Biomedical Engineering Co., Ltd.
See all devices from Shenzhen New Industries Biomedical Engineering Co., Ltd. →
Properties
Other properties (7)
- Sterile: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No