Operating Lamp
by Jiangsu Saikang Medical Equipment Co., Ltd 11 variants
Ref SK-LLD50BModel SK-L201,SK-L202,SK-L204,SK-L205,SK-L206,SK-L207,SK-L208,SK-L210,SK-L212,SK-L213,SK-L260,SK-L261,SK-L262,SK-L274,SK-L275,SK-L276,SK-L226,SK-L278,SK-L227,SK-L275-M,SK-L203,SK-L323,SK-L316,SK-L317,SK-L318,SK-L319,SK-L320,SK-L321,SK-L322,SK-L325,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 | Number697453996OperatingLampVC 16974539962973 | Date11 Jul 2023 | 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- Withdrawn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
- Operating Lamp
- Model / Reference
- SK-L201, SK-L202, SK-L204, SK-L205, SK-L206, SK-L207, SK-L208, SK-L210, SK-L212, SK-L213, SK-L260, SK-L261, SK-L262, SK-L274, SK-L275, SK-L276, SK-L226, SK-L278, SK-L227, SK-L275-M, SK-L203, SK-L323, SK-L316, SK-L317, SK-L318, SK-L319, SK-L320, SK-L321, SK-L322, SK-L325, etc, SK-LLD50B
- Primary DI / UDI-DI
- 16974539962973
- Basic UDI-DI
- 697453996OperatingLampVC
- EMDN Code
- Z129004 Light sources
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000002228
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Jiangsu Saikang Medical Equipment Co., Ltd
See all devices from Jiangsu Saikang Medical Equipment 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