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OK-Proxofile

by Jaintek Co., Ltd. 6 variants

Ref OKP1540/4Model OK-S, OK-P Series

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 linked in EUDAMED

A group certificate may exist

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 Number88001152S-0001U3 Basic UDI-DI 08800115201208UDI-DIDate12 May 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
OK-Strips, OK-Proxofile
Model / Reference
OK-S, OK-P Series, OKP1540/4
Primary DI / UDI-DI
08800115201208
Basic UDI-DI
88001152S-0001U3
EMDN Code
Q010399 Surgical dental devices - other
Device Class
Class IIa
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
KR-MF-000045113
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from Jaintek Co., Ltd.

See all devices from Jaintek Co., Ltd. →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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