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Thumb Spica X-LARGE RIGHT

by Promedics Orthopaedics Limited EUDAMED

Withdrawn No longer placed on the EU market

Ref BULK016/XLR

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50554741B17H Basic UDI-DIDate6 Aug 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Hand Therapy
Model / Reference
BULK016/XLR
Primary DI / UDI-DI
05056356280868
Basic UDI-DI
50554741B17H
EMDN Code
Y060606 Hand orthoses
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000008558
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Promedics Orthopaedics Limited

See all devices from Promedics Orthopaedics Limited →

Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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