Identity
- Trade Name
- iLumin EUDAMED
- Device Name
- Fiberoptic Illuminator EUDAMED
- Model / Reference
- FI-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00893872001332 EUDAMED
- Basic UDI-DI
- 0893872001Fi-10054 EUDAMED
- Direct Marketing DI
- 00893872001332 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
iLumin by Nova Eye, Inc. — 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 | 0893872001Fi-10054 | Class I | Active |
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Manufacturer
- Manufacturer
- Nova Eye, Inc.
- EUDAMED SRN
- US-MF-000011341
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 197e2b4d-a7df-4bba-b498-79d15b2e0924 61 fields · synced Jun 19, 2026