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EYEVAN7285

by EYEVAN Inc. 623 variants

Part of a family of 99 devices: see the family page

Ref 331 50 309Model Plastic

EYEVAN7285 (331 50 309) is a Class I device made by Eyevan Inc., registered in EUDAMED on 31 May 2024 (Basic UDI-DI 458266798RXPLAVT) and listed in FDA GUDID since 9 Sep 2022 (UDI-DI 04582667982234), 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 Number458266798RXPLAVT Basic UDI-DI 04582667982234UDI-DIDate31 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04582667982234 UDI-DI Date9 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 458266798RXPLAVT registered 31 May 2024 Active
  • FDA GUDID UDI-DI 04582667982234 listed 9 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04582667982234
  2. Registered EUDAMED 458266798RXPLAVT

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  • Withdrawn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, 331 50 309
Primary DI / UDI-DI
04582667982234
Basic UDI-DI
458266798RXPLAVT
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

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Properties

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