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UL bundle kit Sensor/Variplus Speed Hand

by Otto Bock Healthcare Products GmbH 12 variants

Ref 70UL38=8-R8-1/4Model 70UL38

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 Number40644110000000070UL38TR Basic UDI-DI 04064411014847UDI-DIDate21 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  • Withdrawn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
70UL38, 70UL38=8-R8-1/4
Primary DI / UDI-DI
04064411014847
Basic UDI-DI
40644110000000070UL38TR
EMDN Code
Y061899 Upper extremity prostheses - other
Device Class
Class I
EU market of registration
Germany
Medical Purpose
Kit for fitting UL user with Speed Hand, electrodes, battery and accessories

Manufacturer details

EUDAMED SRN
AT-PR-000004582

Other devices from Otto Bock Healthcare Products GmbH

See all devices from Otto Bock Healthcare Products GmbH →

Properties

Other properties (5)

  • Sterile: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Endocrine Disruptor: No