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speed.hand - Service, Test

by Otto Bock Healthcare Products GmbH 10 variants

Ref 8E2=L-M-1-OBModel 8E2

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4064411000000000008E2FA Basic UDI-DI 04064411004497UDI-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  • Withdrawn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

Device Name
speed.hand
Model / Reference
8E2, 8E2=L-M-1-OB
Primary DI / UDI-DI
04064411004497
Basic UDI-DI
4064411000000000008E2FA
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