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MyoPro Motion W Left - 25738

by Myomo, Inc.

Ref 25738Model MyoPro 2 Motion W Left

MyoPro Motion W Left - 25738 is a device classified as Class I in the EU and Class II in the US made by Myomo, Inc., registered in EUDAMED on 29 May 2026 (Basic UDI-DI B-00855846007023) and listed in FDA GUDID since 1 Apr 2017 (UDI-DI 00855846007023), withdrawn as of 22 Oct 2026.

Withdrawn Withdrawn in European Union.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00855846007023 Basic UDI-DI 00855846007023UDI-DIDate29 May 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00855846007023 UDI-DI Date1 Apr 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00855846007023 registered 29 May 2026 Withdrawn
  • FDA GUDID UDI-DI 00855846007023 listed 1 Apr 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00855846007023
  2. Registered EUDAMED B-00855846007023

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn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

Specification

EUDAMED · GUDID

Trade name
MyoPro 2 Motion W Left EUDAMED
MyoPro GUDID
Generic name
Psychophysiological biofeedback system
Model / Ref / Catalog
MyoPro 2 Motion W Left, 25738, Motion W Left - 25738
Primary DI / UDI-DI
00855846007023
Basic UDI-DI
B-00855846007023
FDA product code
HCC, IQI, IRE, IQZ
EMDN code
Y060699 Orthoses, upper extremity - other
GMDN term
Psychophysiological biofeedback system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.5050, 890.3475, 890.3420
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MyoPro 2 Motion W Left
25738
GUDID
Motion W Left - 25738
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Elbow orthosisPsychophysiological biofeedback systemHand orthosis

Similar devices in this category

Other devices filed under UPPER EXTREMITY ORTHOSES (SPLINTS AND BRACES).

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)