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EUDAMED last updated this device on Jul 15, 2026
0893872001Fi-2015BiLumin is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Nova Eye, Inc.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
00893872001660FI-201(01)00893872001660
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q0299OPHTHALMIC DEVICES - OTHER3 warnings recorded — scroll inside the panel to see all entries.
OTHER
(1) Federal law restricts this device to sale by or on the order of a physician or licensed practitioner. (2) Use of controls or adjustments or performance of procedures other that those specified herein may result in hazardous radiation exposure. (3) The use of optical instruments with this product will increase eye hazard. (4) Ensure the tip of the connected iTrack device is illuminated before use in the eye. (5) This is a Class 1 laser product per IEC 60825-1:2014 (6) Permanent magnets used in the iLumin light output coupler may cause interference with devices sensitive to magnetic fields. Maintain a minimum separation distance of 6 inches (15 cm) between this product and any medical device that may be affected by magnets. (7) The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater is the risk of ocular damage. Exposure to light from this instrument when operated at maximum intensity will exceed the recommended maximum exposure (RME) of 2.2 J/cm2, unless additional action is taken by the user to minimize exposure, after 38.5 minutes for the laser beam. The risk of retinal injury at an exposure of 2.2 J/cm2 is not high, but because some patients may be more susceptible than others, caution is advised if this radiant exposure is exceeded. However, because of a significant risk of injury at exposures exceeding 10 J/cm2, the user should avoid exposures longer than 175 minutes for the laser beam. (8) Portable and mobile RF communications equipment can affect the iLumin (9)The iLumin should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used.
US-MF-000011341The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Netherlands; available across 8 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Apr 17, 2026 | Still on market |
| Germany | May 4, 2026 | Still on market |
| Spain | Jun 2, 2026 | Still on market |
| Finland | May 1, 2026 | Still on market |
| Iceland | May 1, 2026 | Still on market |
| Norway | May 1, 2026 | Still on market |
| Poland | May 14, 2026 | Still on market |
| Sweden | May 1, 2026 | Still on market |
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
28620238771-00SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →