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EyeMax2 Micro

by Maxtec, Inc. 2 variants

Ref R300P03-004

EyeMax2 Micro (R300P03-004) 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 12 Jun 2023 (UDI-DI 00817770025818), 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00817770025818 UDI-DI Date12 Jun 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number081777002EyeMax2CU Basic UDI-DI 00817770025818UDI-DIDate3 Feb 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081777002EyeMax2CU registered 3 Feb 2022 Active
  • FDA GUDID UDI-DI 00817770025818 listed 12 Jun 2023 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Registered EUDAMED 081777002EyeMax2CU
  2. Listed FDA GUDID 00817770025818

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  • Withdrawn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 Italian EUDAMED
EyeMax2 GUDID
Generic name
Phototherapy infant blanket
Device name
EyeMax 2
Model / Ref / Catalog
R300P03-004, Micro
Primary DI / UDI-DI
00817770025818
Basic UDI-DI
081777002EyeMax2CU
Direct marketing DI
00817770025818
FDA product code
FOK
EMDN code
V0201 Phototherapy masks
GMDN term
Phototherapy infant blanket
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
R300P03-004
GUDID
Micro

Related devices

Category: Phototherapy infant blanket

Similar devices

Also classified as Phototherapy infant blanket.

Other devices from Maxtec, Inc.

See all devices from Maxtec, Inc. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)