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E-Eye

by E-Swin SAS

Ref D029AF001C08A

E-Eye (D029AF001C08A) is a medical device (EU MDD Class IIb; FDA Class II; EMDN category generic photostimulators) made by E-Swin SAS, registered in EUDAMED on 10 Mar 2022 (Basic UDI-DI B-03662824000207), cleared under FDA 510(k) K200616 on 11 Jun 2020 and listed in FDA GUDID since 4 Apr 2022 (UDI-DI 03662824000207), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200616

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03662824000207 UDI-DI Date4 Apr 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-03662824000207 Basic UDI-DI 03662824000207UDI-DIDate10 Mar 2022RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200616 Date11 Jun 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03662824000207 registered 10 Mar 2022 Active
  • FDA 510(k) K200616 decided 11 Jun 2020 Active
  • FDA GUDID UDI-DI 03662824000207 listed 4 Apr 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200616
  2. Registered EUDAMED B-03662824000207
  3. Listed FDA GUDID 03662824000207

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
E-Eye EUDAMED
E>eye C GUDID
Generic name
Light-energy skin surface treatment system applicator
Model / reference
D029AF001C08A
Primary DI / UDI-DI
03662824000207
Basic UDI-DI
B-03662824000207
510(k) Number
FDA product code
GEX, ONF
EMDN code
Z129005 Generic photostimulators
GMDN term
Light-energy skin surface treatment system applicator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
FR-MF-000011807

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS.

Other devices from E-Swin SAS

  • TearStim

    Class IIb

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)