Automatic LVET Software
by Neko Health AB Sweden EUDAMED
Ref Automatic LVET Software
EMDN Z12050792
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number735017092_LVET_MR | Date20 Oct 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- SCAR-28.2.1.0 Issued
Quality management system EU MDR
- Notified body
- Notified body 3022
- Issued
- 20 Oct 2026
- Expires
- 19 Oct 2031
Specification
- Device Name
- Automatic LVET Software
- Model / Reference
- Automatic LVET Software
- Primary DI / UDI-DI
- 07350170923009
- Basic UDI-DI
- 735017092_LVET_MR
- EMDN Code
- Z12050792 Instruments for cardiological polygraphy - medical device software
- Device Class
- Class IIa
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- SE-MF-000045605
Other devices from Neko Health AB
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 07350170923009|735017092_LVET_MR