Identity
- Trade Name
- Shalya iLUX 11 EUDAMED
- Device Name
- Shalya iLUX 10 EUDAMED
- Model / Reference
- OT Light (Shalya iLUX) EUDAMEDL003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89044281011154 EUDAMED
- Basic UDI-DI
- 8904428iLUXGG EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Shalya iLUX 11 by Xcellance Medical Technologies Pvt. 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 | 8904428iLUXGG | Class I | Active |
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Manufacturer
- Manufacturer
- Xcellance Medical Technologies Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000035259
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (1)
- EUDAMED febcd95b-5d51-4d1e-972f-399b7b0c9baf 61 fields · synced Jul 9, 2026