Medical Headlight
by Shenzhen YND Electronic Technology Co., Ltd. 15 variants
Ref YND-WB6TL6Model YND-B2L4, YND-B2L5,YND-B3L4,YND-B3L5,YND-B5L4,YND-B5L5, YND-WB6L4,YND-WB6L5, YND-WB6RL4, YND-WB6RL5, YND-WB6RL6,,YND-WB6TL4,YND-WB6TL5,YND-WB6TL6,YND-B5TL5,YND-B5TL6, YND-B5TL7,YND-B7L5, YND-B7L6, YND-B7L7,YND-B8L6 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 | Number697852234MH01MF 06978522340130 | Date22 May 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- Withdrawn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
- Device Name
- Medical Headlight
- Model / Reference
- YND-B2L4, YND-B2L5, YND-B3L4, YND-B3L5, YND-B5L4, YND-B5L5, YND-WB6L4, YND-WB6L5, YND-WB6RL4, YND-WB6RL5, YND-WB6RL6, YND-WB6TL4, YND-WB6TL5, YND-WB6TL6, YND-B5TL5, YND-B5TL6, YND-B5TL7, YND-B7L5, YND-B7L6, YND-B7L7, YND-B8L6 etc
- Primary DI / UDI-DI
- 06978522340130
- Basic UDI-DI
- 697852234MH01MF
- EMDN Code
- Z12010799 Scialytic lamp lighting systems - other
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000047576
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shenzhen YND Electronic Technology Co., Ltd.
See all devices from Shenzhen YND Electronic 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