Identity
- Trade Name
- iLumin EUDAMEDFDA UDI
- Generic Name
- Ophthalmic procedural light source unit FDA UDI
- Device Name
- Fiberoptic Illuminator EUDAMEDOptical Light Source: Fiberoptic Illuminator, Gen 2 iLumin series of revisions FDA UDI
- Model / Reference
- FI-200 EUDAMEDFDA UDI
- Description
- Optical Light Source: Fiberoptic Illuminator, Gen 2 iLumin series of revisions FDA UDI
Identifiers
- Catalog Number
- 205000 FDA UDI
- Primary DI / UDI-DI
- 00893872001608 EUDAMEDFDA UDI
- Basic UDI-DI
- 0893872001Fi-20059 EUDAMED
- Direct Marketing DI
- 00893872001608 EUDAMED
- 510(k) Number
- K062259 FDA UDI
- 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
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-20059 | 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 9c9b922f-75ed-46bc-8e4c-875513dd2c40 61 fields · synced Jul 20, 2026
- FDA UDI 1d27262f-f054-42bf-a38a-4fbbb67021b7 37 fields · synced May 29, 2026