Identity
- Device Name
- LED Surgical Light EUDAMED
- Model / Reference
- HyLED XE91 EUDAMEDHyLED 730M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948350502680 EUDAMED
- Basic UDI-DI
- 69483505HyLEDX9Series**TS EUDAMED
- Direct Marketing DI
- 06948350502680 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
A comprehensive LED Surgical Light device that offers a range of innovative features and benefits, making it an ideal choice for medical professionals. Learn more about this cutting-edge technology.
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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 | 69483505HyLEDX9Series**TS | Class I | Active |
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Manufacturer
- Manufacturer
- Nanjing Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000019806
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED a56915ff-b1d9-4f4e-b16c-2ab92f848610 61 fields · synced Jul 17, 2026