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Socket Adapter with Rotation Adjustment

by Ottobock SE & Co. KGaA EUDAMED

Active European Union

Ref 4R111=NModel 4R111

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number40327670000000004R111ZG Basic UDI-DIDate30 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Rotatable 4 prong Adapter w/adj screws
Model / Reference
4R111, 4R111=N
Primary DI / UDI-DI
04032767041343
Basic UDI-DI
40327670000000004R111ZG
EMDN Code
Y062409 Transtibial prostheses (for amputation under knee)
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000010487

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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