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EYEVAN7285

by EYEVAN Inc. 623 variants

Part of a family of 15 devices: see the family page

Ref 375E 48 301Model Plastic

EYEVAN7285 (375E 48 301) is a Class I device made by Eyevan Inc., registered in EUDAMED on 30 Jun 2025 (Basic UDI-DI 458266904RXPLAQL) and listed in FDA GUDID since 1 Oct 2025 (UDI-DI 04582669048112), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04582669048112 UDI-DI Date1 Oct 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number458266904RXPLAQL Basic UDI-DI 04582669048112UDI-DIDate30 Jun 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 458266904RXPLAQL registered 30 Jun 2025 Active
  • FDA GUDID UDI-DI 04582669048112 listed 1 Oct 2025 Listed

Timeline

2 dated events

  1. Registered EUDAMED 458266904RXPLAQL
  2. Listed FDA GUDID 04582669048112

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  • Withdrawn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

Generic name
Spectacle frame
Device name
Plastic spectacle frames without lenses
Model / reference
Plastic, 375E 48 301
Primary DI / UDI-DI
04582669048112
Basic UDI-DI
458266904RXPLAQL
FDA product code
HQZ
EMDN code
Q02100202 Plastic spectacle frames without lenses
GMDN term
Spectacle frame
Device class
Class I
Regulation number
886.5842
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
JP-MF-000028437
Authorised representative
EYEVAN Europe FR-AR-000025678

Similar devices in this category

Other devices filed under CORRECTIVE OPTICAL DEVICES.

Other devices from Eyevan Inc.

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Properties

  • Premarket exempt
Other properties (24, all answered No)