Skip to content

Phoropter VRx 16241

by Reichert Inc.

Part of a family of 9 devices: see the family page

Ref 16241Model 16290

Phoropter VRx 16241 is a Class I device made by Reichert Inc., registered in EUDAMED on 11 Mar 2026 (Basic UDI-DI 081255901AUP001Y7) and listed in FDA GUDID since 12 Aug 2025 (UDI-DI 00812559011716), active as of 24 Oct 2026.

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

CE MDR

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/MDR EUDAMED Number081255901AUP001Y7 Basic UDI-DI 00812559011716UDI-DIDate11 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812559011716 UDI-DI Date12 Aug 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081255901AUP001Y7 registered 11 Mar 2026 Active
  • FDA GUDID UDI-DI 00812559011716 listed 12 Aug 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00812559011716
  2. Registered EUDAMED 081255901AUP001Y7

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Phoroptor® VRx Digital Refraction System EUDAMED
Phoropter VRx GUDID
Generic name
Phoropter, manual
Device name
SightChek® Digital Phoroptor
Model / reference
16241, 16290
Primary DI / UDI-DI
00812559011716
Basic UDI-DI
081255901AUP001Y7
FDA product code
HKN
EMDN code
Z12120115 Optometers
GMDN term
Phoropter, manual
Device class
Class I
Regulation number
886.1770
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Phoropter, manual

Similar devices in this category

Other devices filed under OPTOMETERS.

Other devices from Reichert Inc.

See all devices from Reichert Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)