optical
by Wenzhou Well Optical Co., Ltd 82 variants
Ref 06978608000293Model AMPHORA
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 | Number697860800AMPHORA2W 06978608000293 | Date11 Jun 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- Withdrawn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
- AMPHORA, 06978608000293
- Primary DI / UDI-DI
- 06978608000293
- Basic UDI-DI
- 697860800AMPHORA2W
- Direct Marketing DI
- 06978608000293
- 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