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Medical Headlight
EUDAMEDClass I (EU MDR)
Ref YND-B2L5Model 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 etcRef YND-WB6TL5Ref YND-B5L5Ref YND-B7L5
Identity
- Device Name
- Medical Headlight EUDAMED
- 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 EUDAMEDYND-B2L5 EUDAMEDYND-WB6TL5 EUDAMEDYND-B5L5 EUDAMEDYND-B7L5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978522340017 EUDAMED06978522340123 EUDAMED06978522340055 EUDAMED06978522340178 EUDAMED
- Basic UDI-DI
- 697852234MH01MF EUDAMED
- EMDN Code
- Z12010799 SCIALYTIC LAMP LIGHTING SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medical Headlight by Shenzhen YND Electronic Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697852234MH01MF | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen YND Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000047576
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 61831646-e7c9-4bb7-9ca5-ece9db0f3ae4 61 fields · synced Aug 3, 2026
- EUDAMED 086389d7-7eeb-40b2-a428-233f5ac01275 61 fields · synced May 17, 2026
- EUDAMED 2d262ef3-57de-4e2c-8811-e164fe15c734 61 fields · synced May 17, 2026
- EUDAMED 16f8562b-6039-4510-b359-11ba0b151951 61 fields · synced May 18, 2026