Identity
- Trade Name
- BenQ EUDAMED
- Device Name
- BenQ LED Shadowless Surgical Light EUDAMED
- Model / Reference
- TriLite S600 EUDAMED31LL-14004-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879883039 EUDAMED
- Basic UDI-DI
- 471987988TriLiteS60029 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
BenQ by BenQ Medical Technology Corp. — 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 | 471987988TriLiteS60029 | Class I | Active |
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Manufacturer
- Manufacturer
- BenQ Medical Technology Corp.
- EUDAMED SRN
- TW-MF-000012212
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 1ffdff3f-e43e-4f80-a3e4-ca08d1077868 61 fields · synced May 23, 2026