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surgical light
EUDAMEDClass I (EU MDR)
Ref MK-D700500ZF(G)Model MK-D700500ZF(G),MK-D700500ZF,MK-K1000500KL,MK-R700500BW(D),MK-E110WY,MK-E200WY,MK-E500KLA,MK-E300BW,MK-E100HF,MK-E370JD,MK-DL500ZF,MK-E80JD,MK-D500ZF,MK-D700ZF,MK-AL250ZF,MK-B400ZF,MK-B400400ZF,MK-BL400ZF
Identity
- Device Name
- surgical light EUDAMED
- Model / Reference
- MK-D700500ZF(G),MK-D700500ZF,MK-K1000500KL,MK-R700500BW(D),MK-E110WY,MK-E200WY,MK-E500KLA,MK-E300BW,MK-E100HF,MK-E370JD,MK-DL500ZF,MK-E80JD,MK-D500ZF,MK-D700ZF,MK-AL250ZF,MK-B400ZF,MK-B400400ZF,MK-BL400ZF EUDAMEDMK-D700500ZF(G) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976363790985 EUDAMED
- Basic UDI-DI
- 697636379SL001PZ 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 Zhangjiagang Medi Medical Equipment 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 | 697636379SL001PZ | Class I | Active |
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Manufacturer
- Manufacturer
- Zhangjiagang Medi Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000036799
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 0ffba844-189c-4021-bd22-ed73a292e6b9 61 fields · synced Jul 24, 2026