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EUDAMED last updated this device on May 26, 2026
0853061006EyeMax22VEyeMax 2 Regular is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Maxtec, LLC. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
00853061006920R300P01(01)00853061006920
European Medical Device Nomenclature — the EU product classification assigned to this device.
V0201PHOTOTHERAPY MASKS2 warnings recorded — scroll inside the panel to see all entries.
Improper EyeMax2 sizing may lead to patient airway obstruction or inadequate eye protection. The Eyemax2 should only be used while the patient is under the continuous, direct supervision of healthcare professionals.
Primary placement in Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Nov 20, 2008 | Still on market |
US-MF-000003961The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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.
081777002EyeMax2CUOn the marketEyeMax 2 Preemie081777002EyeMax2CUOn the marketEyeMax 2 Preemie 20/pack Italian081777002EyeMax2CUOn the marketEyeMax 2 Regular 20/pack Italian081777002EyeMax2CUOn the marketEyeMax 2, Bioptron Regular081777002EyeMax2CUOn the marketEyeMax 2, Drager Micro MP03770 20/Pack081777002EyeMax2CUOn the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.