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Fundus Camera

by Chongqing Bio NewVision Medical Equipment Ltd. 3 variants

Model Kestrel 300, RetiCam 3100 Plus

Fundus Camera (Kestrel 300) is a Class I device made by Chongqing Bio Newvision Medical Equipment Ltd., registered in EUDAMED on 16 Jul 2025 (Basic UDI-DI 697300960011GD), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697300960011GD Basic UDI-DI Date16 Jul 2025RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Fundus Camera
Model / reference
Kestrel 300, RetiCam 3100 Plus
Primary DI / UDI-DI
06973009600110, 06973009600189
Basic UDI-DI
697300960011GD, 697300960018GT
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)