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Cirrus Hd-Oct 500

by Carl Zeiss Meditec, Inc.

Ref 2660021175356, 2660021185108, 2660021187326Model 500, 5000, 6000

Cirrus Hd-Oct 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 22 May 2026 (Basic UDI-DI 4057748_CIR001_6S), cleared under FDA 510(k) K150977 on 1 Sep 2015 and listed in FDA GUDID since 25 Aug 2016 (UDI-DI 04057748087097), 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) K150977

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_CIR001_6S Basic UDI-DI 04057748087097UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04057748087097 UDI-DI Date25 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK150977 Date1 Sep 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4057748_CIR001_6S registered 22 May 2026 Active
  • FDA 510(k) K150977 decided 1 Sep 2015 Active
  • FDA GUDID UDI-DI 04057748087097 listed 25 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K150977
  2. Listed FDA GUDID 04057748087097
  3. Registered EUDAMED 4057748_CIR001_6S

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  • Withdrawn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
CIRRUS HD-OCT Model 500 EUDAMED
Cirrus Hd-Oct GUDID
Generic name
Ophthalmic spectral-domain optical coherence tomography system
Model / reference
500, 5000, 6000, 2660021175356, 2660021185108, 2660021187326
Primary DI / UDI-DI
04057748087097
Basic UDI-DI
4057748_CIR001_6S
Direct marketing DI
04057748087097
510(k) Number
FDA product code
OBO
EMDN code
Q0299 Ophthalmic devices - other
GMDN term
Ophthalmic spectral-domain optical coherence tomography system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.1570
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, 5000, 6000
2660021175356, 2660021185108, 2660021187326
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 spectral-domain optical coherence tomography system

Cleared under the same submission (K150977)

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
Other properties (24, all answered No)