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Stirrups for Lithotomy Surgery

by Auckland Medical Polymer (Tianjin) Co., Ltd. 3 variants

Ref OTJ004Model OTJ001,OTJ003,OTJ004,OGJ-005

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 Number69534970OTJ247VZ Basic UDI-DI 06953497000296UDI-DIDate16 May 2026RegisteredStatusActive

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  • Withdrawn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
Stirrups for Lithotomy Surgery
Model / Reference
OTJ001, OTJ003, OTJ004, OGJ-005
Primary DI / UDI-DI
06953497000296
Basic UDI-DI
69534970OTJ247VZ
Direct Marketing DI
06953497000296
EMDN Code
Z12011201 Operating chairs
Device Class
Class I
EU 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.

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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