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EyeMax2 R300P03

by Maxtec, Inc.

Part of a family of 21 devices: see the family page

Ref R300P03

EyeMax2 R300P03 is a Class I device made by Maxtec, Inc., registered in EUDAMED on 3 Feb 2022 (Basic UDI-DI 081777002EyeMax2CU) and listed in FDA GUDID since 24 Jan 2019 (UDI-DI 00817770021841), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081777002EyeMax2CU Basic UDI-DI 00817770021841UDI-DIDate3 Feb 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00817770021841 UDI-DI Date24 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081777002EyeMax2CU registered 3 Feb 2022 Active
  • FDA GUDID UDI-DI 00817770021841 listed 24 Jan 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817770021841
  2. Registered EUDAMED 081777002EyeMax2CU

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
EyeMax 2 Micro 20 pack EUDAMED
EyeMax2 GUDID
Generic name
Phototherapy eye protector, reusable
Device name
EyeMax 2
Model / reference
R300P03
Primary DI / UDI-DI
00817770021841
Basic UDI-DI
081777002EyeMax2CU
Direct marketing DI
00817770021841
FDA product code
FOK
EMDN code
V0201 Phototherapy masks
GMDN term
Phototherapy eye protector, reusable
Device class
Class I
Regulation number
880.5270
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Phototherapy eye protector, reusable

Similar devices in this category

Other devices filed under NEONATOLOGY AND PAEDIATRIC DEVICES.

Other devices from Maxtec, Inc.

See all devices from Maxtec, Inc. →

Properties

  • Premarket exempt
  • Lot / batch number
Other properties (23, all answered No)