Identity
- Trade Name
- iLumin EUDAMED
- Device Name
- Fiberoptic Illuminator EUDAMED
- Model / Reference
- FI-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00893872001301 EUDAMED00893872001318 EUDAMED00893872001325 EUDAMED00893872001288 EUDAMED00893872001349 EUDAMED
- Basic UDI-DI
- 0893872001Fi-10054 EUDAMED
- Direct Marketing DI
- 00893872001301 EUDAMED00893872001318 EUDAMED00893872001325 EUDAMED00893872001288 EUDAMED00893872001349 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDFrance EUDAMEDLatvia EUDAMEDGermany EUDAMEDNetherlands 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 (5)
- EUDAMED fe2ee7b7-68da-426c-9eaf-6490778f6a50 61 fields · synced Aug 1, 2026
- EUDAMED eaf1b809-25ed-4363-9086-2157b1d2e37f 61 fields · synced May 17, 2026
- EUDAMED b61b63c0-5d0d-4e03-80c6-452202f015d2 61 fields · synced May 18, 2026
- EUDAMED 12f77e21-930a-4d0c-a64e-d0b984ecd3a2 61 fields · synced May 19, 2026
- EUDAMED add9303d-acf5-47e7-a3ea-9ec115266776 61 fields · synced May 19, 2026