SBAS Software
by Smart Blood Analytics Swiss SA Switzerland EUDAMED
Ref SBAS Software
EMDN V92
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR-006 | Date15 Apr 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR-006 Supplemented
Quality management system EU MDR
- Notified body
- SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ 1304
- Issued
- 15 Apr 2024
- Expires
- 26 Dec 2028
- Reason
- Add device or group
Specification
- Model / Reference
- SBAS Software
- Primary DI / UDI-DI
- 07649996089335
- Basic UDI-DI
- 7649996089SBASRC
- Direct Marketing DI
- 07649996089335
- EMDN Code
- V92 Medical device software - not included in other classes
- Device Class
- Class IIa
- Special Device Type
- Software
- Market of Registration
- Slovenia
Manufacturer details
- EUDAMED SRN
- CH-MF-000024251
- Authorised representative
- Smart Blood Analytics, družba za razvoj modelov umetne inteligence, d.o.o. SI-AR-000024052
Other devices from Smart Blood Analytics Swiss SA
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 14d6aca8-4708-49ed-9b15-108b48242f8c