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myosmart. 13E522=1

by Otto Bock Healthcare Products GmbH

Ref 13E522=1Model 13E522

myosmart. 13E522=1 is a device classified as Class I in the EU and Class II in the US made by Otto Bock Healthcare Products GmbH, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 40644110000000013E522JX) and listed in FDA GUDID since 4 May 2026 (UDI-DI 04064411007672), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40644110000000013E522JX Basic UDI-DI 04064411007672UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04064411007672 UDI-DI Date4 May 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40644110000000013E522JX registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 04064411007672 listed 4 May 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04064411007672
  2. Registered EUDAMED 40644110000000013E522JX

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  • Withdrawn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
myosmart.
Generic name
Myoelectric hand prosthesis
Model / reference
13E522=1, 13E522
Primary DI / UDI-DI
04064411007672
Basic UDI-DI
40644110000000013E522JX
FDA product code
GXY, IQZ
EMDN code
Y061899 Upper extremity prostheses - other
GMDN term
Myoelectric hand prosthesis
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1320, 890.3420
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Similar devices in this category

Other devices filed under UPPER EXTREMITY PROSTHESES - OTHER.

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Properties

  • Lot / batch number
Other properties (24, all answered No)