Identity
- Trade Name
- OK-Strips EUDAMED
- Device Name
- OK-Strips EUDAMEDOK-Strips, OK-Proxofile EUDAMED
- Model / Reference
- OKS25 EUDAMEDOK-S, OK-P Series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800115201444 EUDAMED
- Basic UDI-DI
- B-08800115201444 EUDAMED88001152S-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
EUDAMED
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, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08800115201444 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08800115201444 | 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 (2)
- EUDAMED baff2fbb-4a7a-47e6-9471-948c429ea9c7 61 fields · synced Jul 14, 2026
- EUDAMED 6d327a68-4dba-4bb9-9784-1f4afb9f3b8f 61 fields · synced May 18, 2026