# OK-Strips

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/ok-strips-oks15-2>
- Manufacturer: [Jaintek Co., Ltd.](https://devicerts.com/manufacturers/jaintek-co-ltd) (South Korea)
- Device class: Class IIa (EU MDR)
- EMDN: Q010399 SURGICAL DENTAL DEVICES - OTHER

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 88001152S-0001U3 · UDI-DI 08800115201307 · registered 2025-05-12 · status: Active

## Recalls

No recall on record.

## Identity

- Device name: OK-Strips, OK-Proxofile [EUDAMED]
- Model / reference: OK-S [EUDAMED]; OK-P Series [EUDAMED]; OKS15/2 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 08800115201307 [EUDAMED]
- Basic UDI-DI: 88001152S-0001U3 [EUDAMED]
- EMDN code: Q010399 [EUDAMED]

## Classification

- Device class: Class IIa [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Poland [EUDAMED]

## Properties

- Sterilise before use: Yes [EUDAMED]
- Reusable: Yes [EUDAMED]
- Supplied sterile: No [EUDAMED]
- Implantable: No [EUDAMED]
- Contains latex: No [EUDAMED]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]

## Source and citation

- Cite as: OK-Strips, Jaintek Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/ok-strips-oks15-2 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/ok-strips-oks15-2.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/ok-strips-oks15-2
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.