Sleepiz One+
by Sleepiz AG Switzerland EUDAMED
Ref 05Model 3.0
EMDN Z12030280
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number764999647703T4 | Date3 Sep 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- 3.0, 05
- Primary DI / UDI-DI
- 07649996477057
- Basic UDI-DI
- 764999647703T4
- Direct Marketing DI
- 07649996477057
- EMDN Code
- Z12030280 Vital signs monitoring instruments - hardware accessories
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CH-MF-000011783
- Authorised representative
- MED-RAS GmbH Regulatory Affairs Service DE-AR-000006211
Other devices from Sleepiz AG
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 847963c0-f721-4205-a842-8ede3c1f35c3