surgical light
by Shandong Qufu Healthyou Medical Technology Co., Ltd 29 variants
Ref KYL300Model KYL450,KYL300,KYL200，KYL100,KYLD100,，KYL-Ⅱ700，KYL-Ⅱ500,
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 | Number697893706KYL2S 06978937060845 | Date29 Apr 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- Withdrawn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
- surgical light
- Model / Reference
- KYL450, KYL300, KYL200，KYL100, KYLD100, ，KYL-Ⅱ700，KYL-Ⅱ500
- Primary DI / UDI-DI
- 06978937060845
- Basic UDI-DI
- 697893706KYL2S
- EMDN Code
- Z12010702 Mobile scialytic lamps
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000023300
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shandong Qufu Healthyou Medical Technology Co., Ltd
See all devices from Shandong Qufu Healthyou Medical Technology 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