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Elbow joint for cosmetic hand

by Teh Lin Prosthetic & Orthopaedic lnc

Ref J-HT-007

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4719883460183AB Basic UDI-DI 04719883464125UDI-DIDate1 Jul 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  • Withdrawn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
Elbow joint for cosmetic hand
Model / Reference
J-HT-007
Primary DI / UDI-DI
04719883464125
Basic UDI-DI
4719883460183AB
EMDN Code
Y061815 Transhumeral prostheses (for amputation above elbow)
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000012180
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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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