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CANON INC. CR-2 Plus AF

by Canon Inc.

Ref BT8-1756Model Digital Retinal Camera

CANON INC. CR-2 Plus AF is a device classified as Class I in the EU and Class II in the US made by Canon Inc., registered in EUDAMED on 5 Sep 2023 (Basic UDI-DI 4549292rc01DK), cleared under FDA 510(k) K123208 on 19 Mar 2013 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04549292074338), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123208

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4549292rc01DK Basic UDI-DI 04549292074338UDI-DIDate5 Sep 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number04549292074338 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK123208 Date19 Mar 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4549292rc01DK registered 5 Sep 2023 Active
  • FDA 510(k) K123208 decided 19 Mar 2013 Active
  • FDA GUDID UDI-DI 04549292074338 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K123208
  2. Listed FDA GUDID 04549292074338
  3. Registered EUDAMED 4549292rc01DK

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  • Withdrawn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
Digital Retinal Camera CR-2 Plus AF EUDAMED
Canon Inc. GUDID
Generic name
Ophthalmic fundus camera
Device name
Cr-10
Model / reference
Digital Retinal Camera EUDAMED
BT8-1756 EUDAMED
CR-2 Plus AF GUDID
Primary DI / UDI-DI
04549292074338
Basic UDI-DI
4549292rc01DK
FDA product code
HKI
EMDN code
Z12120114 Ophthalmoscopes
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
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Digital Retinal Camera
BT8-1756
GUDID
CR-2 Plus AF
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.

Related devices

Category: Ophthalmic fundus camera

Similar devices in this category

Other devices filed under OPHTHALMOSCOPES.

Other devices from Canon Inc.

See all devices from Canon Inc. →

Properties

  • Serial number
Other properties (24, all answered No)