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Fundus Camera

by Chongqing Bio NewVision Medical Equipment Ltd.

Ref RetiCam 3100

Fundus Camera (RetiCam 3100) is a device classified as Class I in the EU and Class II in the US made by Chongqing Bio Newvision Medical Equipment Ltd., registered in EUDAMED on 7 Nov 2023 (Basic UDI-DI 697300960001GA), cleared under FDA 510(k) K190954 on 22 Jan 2020 and listed in FDA GUDID since 13 Feb 2020 (UDI-DI 06973009600011), active as of 22 Oct 2026.

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

CE MDR 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) K190954

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697300960001GA Basic UDI-DI 06973009600011UDI-DIDate7 Nov 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06973009600011 UDI-DI Date13 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK190954 Date22 Jan 2020IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697300960001GA registered 7 Nov 2023 Active
  • FDA 510(k) K190954 decided 22 Jan 2020 Active
  • FDA GUDID UDI-DI 06973009600011 listed 13 Feb 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K190954
  2. Listed FDA GUDID 06973009600011
  3. Registered EUDAMED 697300960001GA

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Syseye
Generic name
Ophthalmic fundus camera
Device name
Fundus Camera
Model / reference
RetiCam 3100
Primary DI / UDI-DI
06973009600011
Basic UDI-DI
697300960001GA
510(k) Number
FDA product code
HKI
EMDN code
Q0299 Ophthalmic devices - other
GMDN term
Ophthalmic fundus camera
Device class
Class I EUDAMED
Class II GUDID
Regulation number
886.1120
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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
CN-MF-000026465
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Similar devices in this category

Other devices filed under OPHTHALMIC DEVICES - OTHER.

Other devices from Chongqing Bio Newvision Medical Equipment Ltd.

Properties

  • Serial number
  • Expiration date
Other properties (23, all answered No)