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Operating Light
EUDAMEDClass I (EU MDR)
Ref PROLED H6MModel 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,etcRef PROLED H8MRef LEDD500Ref LEDL200Ref PROLEDL620Ref LEDL500
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 EUDAMEDPROLED H6M EUDAMEDPROLED H8M EUDAMEDLEDD500 EUDAMEDLEDL200 EUDAMEDPROLEDL620 EUDAMEDLEDL500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974423970398 EUDAMED16974423970336 EUDAMED16974423970138 EUDAMED16974423970091 EUDAMED16974423970633 EUDAMED16974423970152 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
Operating Light by Hefei Health Science And Technology Development Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 (6)
- EUDAMED 110c5393-aedc-45fb-9a92-abb7f66004cf 61 fields · synced Sep 17, 2026
- EUDAMED 180f512a-b15e-4484-a940-8692856220f7 61 fields · synced May 11, 2026
- EUDAMED 5f2dd192-1d8c-4eaf-9ef9-2c74bbf57b3b 61 fields · synced May 18, 2026
- EUDAMED 25e957d2-d0d8-4454-810f-57fb04cbede0 61 fields · synced May 18, 2026
- EUDAMED 01c24e91-db5f-44f5-b514-292cb805011c 61 fields · synced May 18, 2026
- EUDAMED a3d06057-a2a5-4da6-9588-c05656fa0005 61 fields · synced May 18, 2026