OK-Proxofile

EUDAMED

Class IIa (EU MDR)

Ref OKSP40Model OK-S, OK-P SeriesRef OKP40/2Ref OKP15/2Ref OKP1540/4Ref OKSP15

by Jaintek Co., Ltd.

Identity

Trade Name: OK-Proxofile EUDAMED
Device Name: OK-Strips, OK-Proxofile EUDAMED
Model / Reference: OK-S, OK-P Series EUDAMED
OKSP40 EUDAMED
OKP40/2 EUDAMED
OKP15/2 EUDAMED
OKP1540/4 EUDAMED
OKSP15 EUDAMED

Identifiers

Primary DI / UDI-DI: 08800115200362 EUDAMED
08800115201253 EUDAMED
08800115201376 EUDAMED
08800115201208 EUDAMED
08800115201437 EUDAMED
Basic UDI-DI: 88001152S-0001U3 EUDAMED
EMDN Code: Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Poland EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

Yes

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

OK-Proxofile by Jaintek Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	88001152S-0001U3	Class IIa	Active

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Manufacturer

Manufacturer: Jaintek Co., Ltd.
EUDAMED SRN: KR-MF-000045113
Authorised Representative: KTR Europe GmbH DE-AR-000005685

Sources (5)

EUDAMED f69a221a-62af-4a81-b7f0-20c4819d1b04 61 fields · synced Jul 30, 2026
EUDAMED ae3df95d-6256-4dd5-9486-28b56dff95da 61 fields · synced May 17, 2026
EUDAMED 0988d591-4f92-4917-96c1-35d124bf00d5 61 fields · synced May 18, 2026
EUDAMED 966e74b6-5ac9-4b69-9fe9-7d8b7ff5c99e 61 fields · synced May 18, 2026
EUDAMED afcbb9e4-d744-41d3-91d1-4c4ea4aff87b 61 fields · synced May 19, 2026