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OK-Strips
EUDAMEDClass IIa (EU MDR)
Ref OKS1560H/4Model OK-S, OK-P SeriesRef OKS60SRRef OKS15SLRef OKS25S/2Ref OKS1580/4Ref OKS15H/2Ref OKS25HRef OKS80S/2Ref OKS60Ref OKS40S/2Ref OKS60/2Ref OKS60SLRef OKS15SW/2Ref OKS40/2Ref OKS40SLRef OKS80/2Ref OKS15HRef OKS60HRef OKS1560/4Ref OKS25SL
Identity
- Trade Name
- OK-Strips EUDAMED
- Device Name
- OK-Strips, OK-Proxofile EUDAMED
- Model / Reference
- OK-S, OK-P Series EUDAMEDOKS1560H/4 EUDAMEDOKS60SR EUDAMEDOKS15SL EUDAMEDOKS25S/2 EUDAMEDOKS1580/4 EUDAMEDOKS15H/2 EUDAMEDOKS25H EUDAMEDOKS80S/2 EUDAMEDOKS60 EUDAMEDOKS40S/2 EUDAMEDOKS60/2 EUDAMEDOKS60SL EUDAMEDOKS15SW/2 EUDAMEDOKS40/2 EUDAMEDOKS40SL EUDAMEDOKS80/2 EUDAMEDOKS15H EUDAMEDOKS60H EUDAMEDOKS1560/4 EUDAMEDOKS25SL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800115200225 EUDAMED08800115201482 EUDAMED08800115201352 EUDAMED08800115201468 EUDAMED08800115201383 EUDAMED08800115201390 EUDAMED08800115200317 EUDAMED08800115201536 EUDAMED08800115200379 EUDAMED08800115201314 EUDAMED08800115201499 EUDAMED08800115201291 EUDAMED08800115201246 EUDAMED08800115201475 EUDAMED08800115201239 EUDAMED08800115201260 EUDAMED08800115201413 EUDAMED08800115200386 EUDAMED08800115200218 EUDAMED08800115201284 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
No
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
OK-Strips 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 (20)
- EUDAMED aecebf89-6235-49c1-a871-06831af73192 61 fields · synced Aug 2, 2026
- EUDAMED 906d07b9-b9bb-4aad-9e61-5de2de196414 61 fields · synced May 16, 2026
- EUDAMED 9ba42652-b4de-40c1-9d58-09574f0027c3 61 fields · synced May 16, 2026
- EUDAMED 93796552-cd66-4169-a235-ac7cc2d3be9e 61 fields · synced May 16, 2026
- EUDAMED 82c5f657-3624-4c84-8781-c57f6216f43a 61 fields · synced May 17, 2026
- EUDAMED 9b06afb6-844a-4055-a4e5-a449694f4ec3 61 fields · synced May 17, 2026
- EUDAMED f2cc4d21-cd8f-4f3e-af17-fbbdac21d0f2 61 fields · synced May 17, 2026
- EUDAMED 61ba0e38-d985-4c8f-bff6-783fa1afbedf 61 fields · synced May 17, 2026
- EUDAMED db10a095-34ed-4e2a-8ceb-ef59aa0140a6 61 fields · synced May 17, 2026
- EUDAMED f140f951-d02e-45eb-8298-28e023d73851 61 fields · synced May 17, 2026
- EUDAMED 3f9f08ad-4e91-463a-9747-16fa8dddf6d6 61 fields · synced May 17, 2026
- EUDAMED 23f9a959-b08e-4470-8415-8d37f3acf8c7 61 fields · synced May 17, 2026
- EUDAMED 5c0a06ad-e455-4229-98ba-540507c67b8f 61 fields · synced May 17, 2026
- EUDAMED 38c8d286-7351-4cdf-8ce9-cd10dee44fe4 61 fields · synced May 17, 2026
- EUDAMED dd39e140-c52e-42ae-bd9e-de74a2921b8b 61 fields · synced May 18, 2026
- EUDAMED bd5a2274-2b9e-4b1b-aee6-c91326bf5265 61 fields · synced May 18, 2026
- EUDAMED 07f4d49a-cd67-4ec6-8d17-807fd3ffedfe 61 fields · synced May 18, 2026
- EUDAMED ca197266-a7fe-4227-a967-7fe078ddc3a6 61 fields · synced May 18, 2026
- EUDAMED ee377d95-58c5-4ebb-9898-669e4fbca009 61 fields · synced May 18, 2026
- EUDAMED 343a9be9-589c-4c9b-830e-2445c4e47257 61 fields · synced May 19, 2026