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Operation Lamp
EUDAMEDClass I (EU MDR)
Ref YDE700/500Model YDE700/500,YDE700/700,YDE500/500,YDE700,YDE500,YDE500D,YDE700/500 A,YDE700/700 A,YDE500/500 A,YDE700 A,YDE500 A,YDE500D A， etcRef YDE-HRef YDK5
Identity
- Device Name
- Operation Lamp EUDAMED
- Model / Reference
- YDE700/500,YDE700/700,YDE500/500,YDE700,YDE500,YDE500D,YDE700/500 A,YDE700/700 A,YDE500/500 A,YDE700 A,YDE500 A,YDE500D A， etc EUDAMEDYDE700/500 EUDAMEDYDE-H EUDAMEDYDK5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978858977802 EUDAMED06978858978557 EUDAMED06978858978465 EUDAMED
- Basic UDI-DI
- 697885897ol009FD EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMEDZ129004 LIGHT SOURCES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDCroatia EUDAMEDBulgaria 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
Operation Lamp by Hefei Mt Medical 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 | 697885897ol009FD | Class I | Active |
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Manufacturer
- Manufacturer
- Hefei Mt Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000008983
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 70bdc4c2-0d84-4743-a749-790574a64bab 61 fields · synced Sep 30, 2026
- EUDAMED 4aeb0a02-39b7-43d2-8c31-b670ed2d6608 61 fields · synced Jul 8, 2026
- EUDAMED acc7f077-44ca-426b-829c-61e5c48b7a3a 61 fields · synced Sep 30, 2026