spinit®
by biosurfit SA Portugal EUDAMED
Ref 950200, 540300, spinitE, 910301, 910101Model strip, spinit® HbA1c, spinit® E, spinit® HbA1c control, spinit® CRP control
EMDN W0501010299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | Number56006094490DEVICE2B | Date12 Feb 2024 | StatusActive |
| European Union | CE/IVDR | Number56006094490DEVICE2B | Date12 Feb 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDD, CE/IVDR Active
Specification
- Device Name
- spinit® stripspinit® HbA1cspinit® Espinit® HbA1c controlspinit® CRP control
- Model / Reference
- strip, 950200, spinit® HbA1c, 540300, spinit® E, spinitE, spinit® HbA1c control, 910301, spinit® CRP control, 910101
- Primary DI / UDI-DI
- 05600609449009, D-540300NK, 05600609449016, D-910301P8, D-910101NW
- Basic UDI-DI
- 56006094490DEVICE2B, B-540300NK, 56006094490SPINITBM, B-910301P8, B-910101NW
- EMDN Code
- W0501010299, W0102060109, W0299, W0101050205, W0101050299
- Device Class
- Class AClass IVD General
- Market of Registration
- PortugalNetherlands
Manufacturer details
- EUDAMED SRN
- PT-MF-000033920
Other devices from biosurfit SA
Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (5)
- EUDAMED 17bf4eda-bedd-429e-a443-1e113d3facac
- EUDAMED D-540300NK|B-540300NK
- EUDAMED 05600609449016|56006094490SPINITBM
- EUDAMED D-910301P8|B-910301P8
- EUDAMED D-910101NW|B-910101NW