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IDI Armboard, EU

by Kyra Medical, Inc. EUDAMED

Active European Union

Ref IDI2005Model Kyra, KTEK Armboards and holders

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08500202851002001PT Basic UDI-DIDate20 Jul 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  • Withdrawn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
Arm Positioners
Model / Reference
Kyra, KTEK Armboards and holders, IDI2005
Primary DI / UDI-DI
00850020285945
Basic UDI-DI
08500202851002001PT
Direct Marketing DI
00850020285945
EMDN Code
Z12011280 Patient positioning instruments - hardware accessories
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000003935
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Kyra Medical, Inc.

See all devices from Kyra Medical, Inc. →

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