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EYEVAN7285

by EYEVAN Inc. 623 variants

Part of a family of 48 devices: see the family page

Ref 358E 46 348Model Plastic

EYEVAN7285 (358E 46 348) is a Class I device made by Eyevan Inc., registered in EUDAMED on 20 Jun 2024 (Basic UDI-DI 458266901RXPLAPD) and listed in FDA GUDID since 24 Nov 2023 (UDI-DI 04582669016272), 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 Number458266901RXPLAPD Basic UDI-DI 04582669016272UDI-DIDate20 Jun 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04582669016272 UDI-DI Date24 Nov 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 458266901RXPLAPD registered 20 Jun 2024 Active
  • FDA GUDID UDI-DI 04582669016272 listed 24 Nov 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04582669016272
  2. Registered EUDAMED 458266901RXPLAPD

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  • Withdrawn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, 358E 46 348
Primary DI / UDI-DI
04582669016272
Basic UDI-DI
458266901RXPLAPD
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)