optical
by Wenzhou Well Optical Co., Ltd 82 variants
Ref 06978608001597Model 2001C2
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 | Number6978608002001C2V8 06978608001597 | Date12 May 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- Withdrawn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
- optical
- Model / Reference
- 2001C2, 06978608001597
- Primary DI / UDI-DI
- 06978608001597
- Basic UDI-DI
- 6978608002001C2V8
- Direct Marketing DI
- 06978608001597
- EMDN Code
- Q02100203 Metal and plastic spectacle frames without lenses
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000047314
- Authorised representative
- Humiss International B.V. NL-AR-000001490
Other devices from Wenzhou Well Optical 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