ClinSpot®
by RECIPE Chemicals + Instruments GmbH Germany EUDAMED
Ref MS10000
EMDN W01010402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-MS10000NQ | Date11 May 2023 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS)
- Model / Reference
- MS10000
- Primary DI / UDI-DI
- D-MS10000NQ
- Basic UDI-DI
- B-MS10000NQ
- EMDN Code
- W01010402 Multiple substrates only - clin. chem lab r.
- Device Class
- Class IVD Annex II List B
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000032553
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 8a983634-1bce-4d16-8223-d2d04d20cf37