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MyoHand VariPlus Speed

by Otto Bock Healthcare Products GmbH 24 variants

Ref 8E38=8-R7 3/4-OBModel 8E38=8

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4064411000000008E38=8RS Basic UDI-DI 04064411257121UDI-DIDate8 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
8E38=8, 8E38=8-R7 3/4-OB
Primary DI / UDI-DI
04064411257121
Basic UDI-DI
4064411000000008E38=8RS
EMDN Code
Y061899 Upper extremity prostheses - other
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
AT-MF-000002920

Other devices from Otto Bock Healthcare Products GmbH

See all devices from Otto Bock Healthcare Products GmbH →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No