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Fundus Camera

by Chongqing Bio NewVision Medical Equipment Ltd. 3 variants

Model VX625

Fundus Camera (VX625) is a Class I device made by Chongqing Bio Newvision Medical Equipment Ltd., registered in EUDAMED on 16 Jul 2025 (Basic UDI-DI 697300960031GK) and cleared under FDA 510(k) K190954 on 22 Jan 2020, active as of 23 Oct 2026.

Active European Union and United States

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190954↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697300960031GK Basic UDI-DI 06973009600318UDI-DIDate16 Jul 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK190954 Date22 Jan 2020IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697300960031GK registered 16 Jul 2025 Active
  • FDA 510(k) K190954 decided 22 Jan 2020 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K190954
  2. Registered EUDAMED 697300960031GK

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Device name
Fundus Camera
Model / reference
VX625
Primary DI / UDI-DI
06973009600318
Basic UDI-DI
697300960031GK
EMDN code
Q0299 Ophthalmic devices - other
Device class
Class I
EU registration type
Standard device
EU market of registration
France

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

Other properties (14, all answered No)