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surgical light
EUDAMEDClass I (EU MDR)
Ref KDL300Model KDL100，KDL200，KDL300，KDL300/300,KDL450，KDL500/300，KDL-Ⅱ500/500,KDL-Ⅱ700,KDL-Ⅱ500，KDL-Ⅱ700/500，KDL-Ⅱ700/700，
Identity
- Device Name
- surgical light EUDAMED
- Model / Reference
- KDL100，KDL200，KDL300，KDL300/300,KDL450，KDL500/300，KDL-Ⅱ500/500,KDL-Ⅱ700,KDL-Ⅱ500，KDL-Ⅱ700/500，KDL-Ⅱ700/700， EUDAMEDKDL300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978937060715 EUDAMED
- Basic UDI-DI
- 697893706KDLYQ EUDAMED
- EMDN Code
- Z12010701 FIXED 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
Category: Operating room light system
surgical light by Shandong Qufu Healthyou Medical Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697893706KDLYQ | 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 9efb9e9a-1fc6-47e4-bc54-5635af1b6694 61 fields · synced Jun 19, 2026