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Ultramatic RX Master Phoropter 11635B

by Reichert Inc.

Ref 11635BModel 11636

Ultramatic RX Master Phoropter 11635B is a Class I device made by Reichert Inc., registered in EUDAMED on 11 Mar 2026 (Basic UDI-DI 081255901MNP0012R) and listed in FDA GUDID since 12 Aug 2025 (UDI-DI 00812559010269), 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 Number081255901MNP0012R Basic UDI-DI 00812559010269UDI-DIDate11 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812559010269 UDI-DI Date12 Aug 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081255901MNP0012R registered 11 Mar 2026 Active
  • FDA GUDID UDI-DI 00812559010269 listed 12 Aug 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00812559010269
  2. Registered EUDAMED 081255901MNP0012R

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  • Withdrawn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
Ultramatic RX Master™ Phoroptor® EUDAMED
Ultramatic RX Master Phoropter GUDID
Generic name
Phoropter, manual
Device name
Illuminated Phoroptor®
Model / reference
11635B, 11636
Primary DI / UDI-DI
00812559010269
Basic UDI-DI
081255901MNP0012R
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

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Properties

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