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The Exphand

by ExpHand Prosthetics Ltd EUDAMED

Active European Union EUDAMED: not on the EU market

Ref EXP001-LSD0

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506110465EXP001WD Basic UDI-DIDate27 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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

Model / Reference
EXP001-LSD0
Primary DI / UDI-DI
05061104651449
Basic UDI-DI
506110465EXP001WD
EMDN Code
Y061809 Transradial prostheses (for amputation under elbow)
Device Class
Class I

Manufacturer details

EUDAMED SRN
UK-MF-000042457
Authorised representative
International Associates Auditing & Certification Limited IE-AR-000002248

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