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Rail Clamps (Universal)

by Auckland Medical Polymer (Tianjin) Co., Ltd. EUDAMED

Active European Union

Ref OGJ-005Model OTJ001,OTJ003,OTJ004,OGJ-005

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69534970OTJ247VZ Basic UDI-DIDate16 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Stirrups for Lithotomy Surgery
Model / Reference
OTJ001, OTJ003, OTJ004, OGJ-005
Primary DI / UDI-DI
06953497009800
Basic UDI-DI
69534970OTJ247VZ
Direct Marketing DI
06953497009800
EMDN Code
Z12011201 Operating chairs
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000033571
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Auckland Medical Polymer(Tianjin) Co., Ltd.

See all devices from Auckland Medical Polymer(Tianjin) Co., Ltd. →

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