Identity
- Trade Name
- BenQ EUDAMED
- Device Name
- BenQ LED Shadowless Surgical Light EUDAMED
- Model / Reference
- TriLite LS800 EUDAMED31LL-51004-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879883077 EUDAMED
- Basic UDI-DI
- 471987988TriLiteLS800N5 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
BenQ by BenQ Medical Technology Corp. — 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 | 471987988TriLiteLS800N5 | 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 4c0f3c51-1817-4c07-8a08-40fc676d7312 61 fields · synced May 23, 2026