Identity
- Trade Name
- iLumin EUDAMEDFDA UDI
- Generic Name
- Ophthalmic procedural light source unit FDA UDI
- Device Name
- Fiberoptic Illuminator EUDAMEDOptical Light Source- Fiberoptic Illuminator FDA UDI
- Model / Reference
- FI-100 EUDAMEDFDA UDI
- Description
- Optical Light Source- Fiberoptic Illuminator FDA UDI
Identifiers
- Catalog Number
- 200529 FDA UDI
- Primary DI / UDI-DI
- 00893872001073 EUDAMEDFDA UDI
- Basic UDI-DI
- 0893872001Fi-10054 EUDAMED
- Direct Marketing DI
- 00893872001073 EUDAMED
- FDA Product Code
- MPA FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic procedural light source unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 8 Inch FDA UDILength — 14 Inch FDA UDIWeight — 3.048 Pound FDA UDIHeight — 4 Inch FDA UDIWidth — 7 Inch FDA UDIDepth — 4.5 Inch FDA UDI
iLumin by Nova Eye, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0893872001Fi-10054 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nova Eye, Inc.
- EUDAMED SRN
- US-MF-000011341
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED d2e38da4-7239-4814-81a8-a89bfb434a34 61 fields · synced Jul 26, 2026
- FDA UDI 745d58ab-90e5-4f74-bc64-29f15de460dd 37 fields · synced May 30, 2026