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Operating Light
EUDAMEDClass I (EU MDR)
Ref LEDB260Model LEDD700/700,LEDD700,LEDD620/620,LEDD620,LEDD500/500,LEDD500,LEDD700/500,LEDD730/730,LEDD730,LEDD740/740,LEDD740,LEDD730/740,LEDD260/260,LEDD260,LEDD200/200, LEDD200,LEDB700,LEDB620,LEDB500,LEDB730,LEDB740,etc
Identity
- Device Name
- Operating Light EUDAMED
- Model / Reference
- LEDD700/700,LEDD700,LEDD620/620,LEDD620,LEDD500/500,LEDD500,LEDD700/500,LEDD730/730,LEDD730,LEDD740/740,LEDD740,LEDD730/740,LEDD260/260,LEDD260,LEDD200/200, LEDD200,LEDB700,LEDB620,LEDB500,LEDB730,LEDB740,etc EUDAMEDLEDB260 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974423970701 EUDAMED
- Basic UDI-DI
- 697442397Light001LQ 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
Operating Light by Hefei Health Science And Technology Development 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 | 697442397Light001LQ | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000011677
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 94b7974a-0f68-486c-9282-41d90153624d 61 fields · synced Jun 19, 2026