Oxygen Concentrator
by Foshan Care Medical Technology Co. Ltd. EUDAMED
Active
Ref ZY-5AC
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697107205ZY10ABJH | Date10 Oct 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Oxygen Concentrator
- Model / Reference
- ZY-5AC
- Primary DI / UDI-DI
- 06971072050092
- Basic UDI-DI
- 697107205ZY10ABJH
- Direct Marketing DI
- 06971072050092
- EMDN Code
- Z12159004 Oxygen concentrators
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000018871
- Authorised representative
- Everbiz GmbH DE-AR-000008964
Other devices from Foshan Care Medical Technology Co., Ltd.
Properties
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