Identity
- Trade Name
- Shalya iLUX 12 EUDAMED
- Device Name
- Shalya iLUX 10 EUDAMED
- Model / Reference
- OT Light (Shalya iLUX) EUDAMEDL004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89044281011222 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
Shalya iLUX 12 by Xcellance Medical Technologies Pvt. 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 | 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 d69ae955-e463-49c4-a9f2-e6df43fc2571 61 fields · synced Jul 24, 2026