Bedfordmed
Ref L700/700Model L700/700, L700/500, L500/500, L700, L500, V LED700/700, V LED700/500, V LED500/500, V LED700, V LED500, V LED700 MOBILE, V LED500 MOBILE, II LED700/700, II LED700/500, etc
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 | Number697756389SSOL001GN 06977563890000 | Date18 Jun 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- Withdrawn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 Shadowless Operating Light
- Model / Reference
- L700/700, L700/500, L500/500, L700, L500, V LED700/700, V LED700/500, V LED500/500, V LED700, V LED500, V LED700 MOBILE, V LED500 MOBILE, II LED700/700, II LED700/500, etc
- Primary DI / UDI-DI
- 06977563890000
- Basic UDI-DI
- 697756389SSOL001GN
- EMDN Code
- Z12010701, Z12010702, Z12010780, Z12010785, Z12010799
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000042184
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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