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MyoPro 2+ Motion W Left - 28460 rev1

by Myomo, Inc.

Ref 28460Model MyoPro 2+ Motion G Right

MyoPro 2+ Motion W Left - 28460 rev1 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 Apr 2026 (Basic UDI-DI 0855846007MyoPro2V4) and listed in FDA GUDID since 28 Aug 2021 (UDI-DI 00855846007139), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0855846007MyoPro2V4 Basic UDI-DI 00855846007139UDI-DIDate29 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00855846007139 UDI-DI Date28 Aug 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0855846007MyoPro2V4 registered 29 Apr 2026 Active
  • FDA GUDID UDI-DI 00855846007139 listed 28 Aug 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00855846007139
  2. Registered EUDAMED 0855846007MyoPro2V4

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  • Withdrawn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
MyoPro 2+ Motion W Left EUDAMED
MyoPro 2+ GUDID
Generic name
Psychophysiological biofeedback system
Device name
MyoPro 2+ Motion G Right
Model / Ref / Catalog
MyoPro 2+ Motion G Right, 28460, Motion W Left - 28460 rev1
Primary DI / UDI-DI
00855846007139
Basic UDI-DI
0855846007MyoPro2V4
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
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MyoPro 2+ Motion G Right
28460
GUDID
Motion W Left - 28460 rev1
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 ORTHOSES, UPPER EXTREMITY - OTHER.

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Properties

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