Teqler
by ZOGEAR Medical Co., Ltd. 4 variants
Ref REF T220510Gr1Model CW001-1,CW001-2,CW001-3,CW001-4,CW001-5,CW001-6,CW001-7,CW001-8
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 | Number697484312CW001G2 04260306775958 | Date2 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- Withdrawn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
- Device Name
- Dental cotton rolls
- Model / Reference
- CW001-1,CW001-2,CW001-3,CW001-4,CW001-5,CW001-6,CW001-7,CW001-8, REF T220510Gr1
- Primary DI / UDI-DI
- 04260306775958
- Basic UDI-DI
- 697484312CW001G2
- 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