Surgical Headlight
by Zhejiang FuDe Medphotonic Co., Ltd. 8 variants
Ref Aspholight FD-W8
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 | Number697653601A001DV 06976536010193 | Date25 Oct 2024 | 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- Withdrawn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
- Surgical Headlight
- Model / Reference
- Aspholight FD-W8
- Primary DI / UDI-DI
- 06976536010193
- Basic UDI-DI
- 697653601A001DV
- EMDN Code
- L80 Surgical instruments, reusable - various accessories
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000036121
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
Other devices from Zhejiang FuDe Medphotonic 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