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surgical light
EUDAMEDClass I (EU MDR)
Ref KYLED3Model KYLED500，KYLED200，KYLED5，KYLED3
Identity
- Device Name
- surgical light EUDAMED
- Model / Reference
- KYLED500，KYLED200，KYLED5，KYLED3 EUDAMEDKYLED3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978937060548 EUDAMED
- Basic UDI-DI
- 697893706KYLED23 EUDAMED
- EMDN Code
- Z12010702 MOBILE SCIALYTIC LAMPS 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
surgical light by Shandong Qufu Healthyou Medical 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 | 697893706KYLED23 | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Qufu Healthyou Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000023300
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 586bbf46-53ef-46e2-8615-33df5ff1022c 61 fields · synced Oct 6, 2026