Skip to content

OK-Strips

by Jaintek Co., Ltd. 22 variants

Part of a family of 28 devices: see the family page

Ref OKS15/2Model OK-S, OK-P Series

OK-Strips (OKS15/2) is a medical device (EU MDR Class IIa; EMDN category surgical dental devices) made by Jaintek Co., Ltd., registered in EUDAMED on 12 May 2025 (Basic UDI-DI 88001152S-0001U3), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88001152S-0001U3 Basic UDI-DI 08800115201307UDI-DIDate12 May 2025RegisteredStatusActive

Official records

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  • Withdrawn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, OKS15/2
Primary DI / UDI-DI
08800115201307
Basic UDI-DI
88001152S-0001U3
EMDN code
Q010399 Surgical dental devices - other
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Poland

Manufacturer details

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

Similar devices in this category

Other devices filed under SURGICAL DENTAL DEVICES - OTHER.

Other devices from Jaintek Co., Ltd.

See all devices from Jaintek Co., Ltd. →

Properties

  • Sterilise before use
  • Reusable
Other properties (12, all answered No)