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Keratograph 5M 7700

by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Ref 77000

Keratograph 5M 7700 is a device classified as Class IIa in the EU and Class I in the US made by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung, registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI B-04049584000477) and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 04049584000477), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04049584000477 Basic UDI-DI 04049584000477UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049584000477 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04049584000477 registered 15 Jul 2026 Active
  • FDA GUDID UDI-DI 04049584000477 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049584000477
  2. Registered EUDAMED B-04049584000477

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Keratograph 5M
Generic name
Corneal topography system
Model / reference
77000 EUDAMED
7700 GUDID
Primary DI / UDI-DI
04049584000477
Basic UDI-DI
B-04049584000477
FDA product code
MMQ
EMDN code
Z12120123 Computerised corneal topographs
GMDN term
Corneal topography system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
886.1350
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Weight — 6.1 Kilogram
Height — 512 Millimeter
Depth — 400 Millimeter
Width — 275 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
77000
GUDID
7700
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Corneal topography system

Similar devices in this category

Other devices filed under COMPUTERISED CORNEAL TOPOGRAPHS.

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (20, all answered No)