Identity
- Trade Name
- Adhesive Electrodes for TENS EUDAMED
- Device Name
- Adhesive Electrodes for TENS EUDAMED
- Model / Reference
- PL-029K-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971071599073 EUDAMED
- Basic UDI-DI
- 697107159000000001EL EUDAMED
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Adhesive Electrodes for TENS by JKH Health Co., Ltd. — Class I — 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 | 697107159000000001EL | Class I | Active |
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Manufacturer
- Manufacturer
- JKH Health Co., Ltd.
- EUDAMED SRN
- CN-MF-000035240
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED c866099f-6a72-4d64-968f-cedd5a586e1d 61 fields · synced Jun 19, 2026