Braided cotton rolls
by ZOGEAR Medical Co., Ltd. 4 variants
Ref CW010-2Model CW010-1,CW010-2,CW010-3,CW010-4
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 | Number697484312CW010G3 06974843121304 | Date3 Nov 2026 | 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- Withdrawn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
- CW010-1, CW010-2, CW010-3, CW010-4
- Primary DI / UDI-DI
- 06974843121304
- Basic UDI-DI
- 697484312CW010G3
- EMDN Code
- Q019004 Dental cotton rolls
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000012353
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Other devices from ZOGEAR Medical 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