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OptochekPlus 15170

by Reichert Inc.

Ref 15170

OptochekPlus 15170 is a device classified as Class IIa in the EU and Class II in the US made by Reichert Inc., registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI B-00812559012249) and listed in FDA GUDID since 12 Aug 2025 (UDI-DI 00812559012249), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00812559012249 Basic UDI-DI 00812559012249UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812559012249 UDI-DI Date12 Aug 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00812559012249 registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI 00812559012249 listed 12 Aug 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00812559012249
  2. Registered EUDAMED B-00812559012249

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  • Withdrawn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
OptoChek® Plus EUDAMED
OptochekPlus GUDID
Generic name
Automated ophthalmic refractometer
Model / reference
15170
Primary DI / UDI-DI
00812559012249
Basic UDI-DI
B-00812559012249
FDA product code
HKL, HKO
EMDN code
Z12120113 Ophthalmometers
GMDN term
Automated ophthalmic refractometer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.1780, 886.1760
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Automated ophthalmic refractometerBench-top keratometer

Similar devices in this category

Other devices filed under OPHTHALMOMETERS.

Other devices from Reichert Inc.

See all devices from Reichert Inc. →

Properties

  • Measuring function
  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)