Oxisept
by Живас Оод Bulgaria EUDAMED
Ref zh013/1/en/01
EMDN D0599
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3800228240134W | Date18 Aug 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2025-MDR/QS-043 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 15 Aug 2025
- Expires
- 15 Aug 2028
Specification
- Model / Reference
- zh013/1/en/01
- Primary DI / UDI-DI
- 03800228240465
- Basic UDI-DI
- 3800228240134W
- EMDN Code
- D0599 Oxygen producers for disinfection of medical devices - other
- Device Class
- Class IIb
- Market of Registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- BG-MF-000019745
Other devices from Живас Оод
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 359b318f-7de8-41c1-bead-d1ca77e30ea2