Central Axis 中央轴
by Ondal Medical Systems (Suzhou) Co. Ltd.
Ref Central Axis Rectangular Tube, Ceiling Tube
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4061591001469SA 04061591001551 | Date7 May 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Central Axis Rectangular Tube, Ceiling Tube
- Primary DI / UDI-DI
- 04061591001551
- Basic UDI-DI
- 4061591001469SA
- Direct Marketing DI
- 04061591001551
- EMDN Code
- V9099 Various devices not included in other classes - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000046644
- Authorised representative
- Ondal Medical Systems GmbH DE-AR-000005182
Other devices from Ondal Medical Systems (Suzhou) 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