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Hand & Wrist Splint - Single Sided

by Ersa Med Medi̇kal Ve Ortopedi̇ Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ EUDAMED

Active European Union

Ref ERSA-206-LEFTModel REF-19

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86825110ER150HA Basic UDI-DIDate1 Oct 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  • Withdrawn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
Hand & Wrist Splint - Both Sided
Model / Reference
REF-19, ERSA-206-LEFT
Primary DI / UDI-DI
08682511001527
Basic UDI-DI
86825110ER150HA
EMDN Code
Y060630 Shoulder-elbow-wrist- hand orthoses
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000044533

Other devices from Ersa Med Medi̇kal Ve Ortopedi̇ Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Ersa Med Medi̇kal Ve Ortopedi̇ Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

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