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Medical Irrigation Tower

by Auckland Medical Polymer (Tianjin) Co., Ltd. 4 variants

Ref OKL-JY03Model OKL-JY01(QIT01)、OKL-JY02、OKL-JY03、OKL-JY04

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 Number69534970OTY070YT Basic UDI-DI 06953497000531UDI-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  • Withdrawn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
Medical Irrigation Tower
Model / Reference
OKL-JY01(QIT01)、OKL-JY02、OKL-JY03、OKL-JY04, OKL-JY03
Primary DI / UDI-DI
06953497000531
Basic UDI-DI
69534970OTY070YT
Direct Marketing DI
06953497000531
EMDN Code
V80 Clinical use accessories not included in other classes
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.

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