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Olh #edp

by Innovative Orthopedic Technologies IOT AG

Ref 9814030

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 Number037016023DT008PURISTAK Basic UDI-DI 03701602300457UDI-DIDate6 May 2024RegisteredStatusActive

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  • Withdrawn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
PURIST Leg Positioning System
Model / Reference
9814030
Primary DI / UDI-DI
03701602300457
Basic UDI-DI
037016023DT008PURISTAK
Direct Marketing DI
03701602300457
EMDN Code
Z12011299 Patient positioning instruments – other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CH-MF-000041418
Authorised representative
Blue Broccoli GmbH LI-AR-000000233

Other devices from Innovative Orthopedic Technologies IOT AG

See all devices from Innovative Orthopedic Technologies IOT AG →

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