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Iontophoresis Electrode Treatment Kit
EUDAMEDClass I (EU MDR)
Ref ION-T series electrodes：ION-T02Model ION-T series: ION-T01/ION-T02/ION-T03/ION-T04/ION-T05
Identity
- Trade Name
- IONTOPHORESIS ELECTRODE TREATMENT KIT EUDAMED
- Device Name
- IONTOPHORESIS ELECTRODE TREATMENT KIT EUDAMED
- Model / Reference
- ION-T series: ION-T01/ION-T02/ION-T03/ION-T04/ION-T05 EUDAMEDION-T series electrodes：ION-T02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973602730665 EUDAMED
- Basic UDI-DI
- 697360273ION-T0KE EUDAMED
- Direct Marketing DI
- 06973602730665 EUDAMED
- EMDN Code
- Z120604 IONTOPHORESIS EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Iontophoresis Electrode Treatment Kit by Top-Rank Health Care 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 | 697360273ION-T0KE | Class I | Active |
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Manufacturer
- Manufacturer
- TOP-RANK Health Care Co., Ltd.
- EUDAMED SRN
- CN-MF-000014102
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 3fb433bc-6d81-4d56-975d-9650155b508a 61 fields · synced Jun 19, 2026