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Clarus 500

by Carl Zeiss Meditec, Inc.

Ref 2660021166134, 2660021173632, 2660021184538Model 500, 700

Clarus 500 is a device classified as Class IIa in the EU and Class II in the US made by Carl Zeiss Meditec, Inc., registered in EUDAMED on 20 May 2026 (Basic UDI-DI 4057748_CLA001_26), cleared under FDA 510(k) K181444 on 10 Jan 2019 and listed in FDA GUDID since 25 Sep 2017 (UDI-DI 04057748096037), 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) K181444

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 Number4057748_CLA001_26 Basic UDI-DI 04057748096037UDI-DIDate20 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK181444 Date10 Jan 2019DecidedStatusActive
United StatesGUDID listing GUDID Number04057748096037 UDI-DI Date25 Sep 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4057748_CLA001_26 registered 20 May 2026 Active
  • FDA 510(k) K181444 decided 10 Jan 2019 Active
  • FDA GUDID UDI-DI 04057748096037 listed 25 Sep 2017 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 04057748096037
  2. Cleared FDA 510(k) K181444
  3. Registered EUDAMED 4057748_CLA001_26

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  • Withdrawn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
Clarus 500 EUDAMED
Clarus GUDID
Generic name
Ophthalmic fundus camera
Model / reference
500, 700, 2660021166134, 2660021173632, 2660021184538
Primary DI / UDI-DI
04057748096037
Basic UDI-DI
4057748_CLA001_26
Direct marketing DI
04057748096037
510(k) Number
FDA product code
QER
EMDN code
Q0299 Ophthalmic devices - other
GMDN term
Ophthalmic fundus camera
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.1120
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
500, 700
2660021166134, 2660021173632, 2660021184538
GUDID
500
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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

Cleared under the same submission (K181444)

Similar devices in this category

Other devices filed under OPHTHALMIC DEVICES - OTHER.

Other devices from Carl Zeiss Meditec, Inc.

See all devices from Carl Zeiss Meditec, Inc. →

Properties

  • Measuring function
  • Prescription use
Other properties (23, all answered No)