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surgical light
EUDAMEDClass I (EU MDR)
Ref KDLED200Model KDLED200,KDLED700,KDLED500,KDLED500/500，KDLED700/500,KDLED700/700,KDLED720/520，KDLED5/5，KDLED5/3，KDLED3/3，KDLED5，KDLED3，Ref KDLED500/500Ref KDK5Model KDK4，KDK5,KDK9,KDK12，KDK12/5Ref KDK4Ref KYK5Model KYK4，KYK5Ref KDK12Ref KDLED500Ref KDLED5Ref KDZF500/500Model KDZF500，KDZF700，KYZF500，KYZF600，KDZF500/500，KDZF700/500，KDZF700/700，Ref KDLED700/500Ref KYL200Model KYL450,KYL300,KYL200，KYL100,KYLD100,，KYL-Ⅱ700，KYL-Ⅱ500,Ref KDLED5/3Ref KYLED5Model KYLED500，KYLED200，KYLED5，KYLED3Ref KYL300Ref KDZF700/500Ref KDZF700/700Ref KYK4Ref KDK9
Identity
- Device Name
- surgical light EUDAMED
- Model / Reference
- KDLED200,KDLED700,KDLED500,KDLED500/500，KDLED700/500,KDLED700/700,KDLED720/520，KDLED5/5，KDLED5/3，KDLED3/3，KDLED5，KDLED3， EUDAMEDKDLED200 EUDAMEDKDLED500/500 EUDAMEDKDK4，KDK5,KDK9,KDK12，KDK12/5 EUDAMEDKDK5 EUDAMEDKDK4 EUDAMEDKYK4，KYK5 EUDAMEDKYK5 EUDAMEDKDK12 EUDAMEDKDLED500 EUDAMEDKDLED5 EUDAMEDKDZF500，KDZF700，KYZF500，KYZF600，KDZF500/500，KDZF700/500，KDZF700/700， EUDAMEDKDZF500/500 EUDAMEDKDLED700/500 EUDAMEDKYL450,KYL300,KYL200，KYL100,KYLD100,，KYL-Ⅱ700，KYL-Ⅱ500, EUDAMEDKYL200 EUDAMEDKDLED5/3 EUDAMEDKYLED500，KYLED200，KYLED5，KYLED3 EUDAMEDKYLED5 EUDAMEDKYL300 EUDAMEDKDZF700/500 EUDAMEDKDZF700/700 EUDAMEDKYK4 EUDAMEDKDK9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978937060418 EUDAMED06978937060487 EUDAMED06978937060678 EUDAMED06978937060661 EUDAMED06978937060814 EUDAMED06978937060647 EUDAMED06978937060470 EUDAMED06978937060449 EUDAMED06978937060593 EUDAMED06978937060500 EUDAMED06978937060838 EUDAMED06978937060456 EUDAMED06978937060555 EUDAMED06978937060845 EUDAMED06978937060616 EUDAMED06978937060623 EUDAMED06978937060807 EUDAMED06978937060685 EUDAMED
- Basic UDI-DI
- 697893706KDLEDVD EUDAMED697893706KDKYN EUDAMED697893706KYK2Q EUDAMED697893706KDZFX3 EUDAMED697893706KYL2S EUDAMED697893706KYLED23 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMEDZ12010702 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
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 | 697893706KDLEDVD | 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 (18)
- EUDAMED 5a1c96b4-7266-44f7-a1b3-63b25bcc3b2b 61 fields · synced Aug 2, 2026
- EUDAMED 8a907425-ebda-483c-84d8-046f5eddd22e 61 fields · synced May 16, 2026
- EUDAMED c4bb87f4-ba75-454a-b38c-8448e7287dbf 61 fields · synced May 16, 2026
- EUDAMED a8b3192e-9eb8-4650-8648-388ded35bb2f 61 fields · synced May 17, 2026
- EUDAMED 25caa296-946a-4518-8697-0353776ebb7a 61 fields · synced May 17, 2026
- EUDAMED 9ad4ae6a-685a-4ae6-a685-06036d457d2c 61 fields · synced May 17, 2026
- EUDAMED f0f0e5de-4603-4340-8221-c5564f26d12a 61 fields · synced May 17, 2026
- EUDAMED a493ff4c-62e0-4cbd-ab71-9b048e36c039 61 fields · synced May 17, 2026
- EUDAMED 1fe8457c-9c55-474a-a336-f02962d8b89e 61 fields · synced May 18, 2026
- EUDAMED 898ded38-4d3e-441e-a014-a215e50d8a0e 61 fields · synced May 18, 2026
- EUDAMED 97531ec4-ffd3-429e-8879-a283ad320a20 61 fields · synced May 18, 2026
- EUDAMED 70d6fcf4-7380-48a3-b18d-5355954c57d6 61 fields · synced May 18, 2026
- EUDAMED 0e65cd60-8f34-4c0a-90ac-69bae6aebdb7 61 fields · synced May 18, 2026
- EUDAMED f69c4e2e-dd93-4cbb-86c2-3ff4882ff770 61 fields · synced May 18, 2026
- EUDAMED e3ad3706-4073-424f-9586-ac1dd5e47d2f 61 fields · synced May 18, 2026
- EUDAMED 45a7a002-ac0f-4b80-b734-9700e6968532 61 fields · synced May 18, 2026
- EUDAMED 79eec31d-7ac0-4505-8c4e-307814c1bcd6 61 fields · synced May 18, 2026
- EUDAMED d4a0cb9d-f709-4b47-87aa-47bd05d3aee3 61 fields · synced May 19, 2026