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Iontophoresis Electrode Treatment Kit
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref ION-T series electrodesModel ION-T series: ION-T01/ION-T02/ION-T03/ION-T04/ION-T05Ref ION-T series electrodes：ION-T03
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 EUDAMEDION-T series electrodes：ION-T03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973602730658 EUDAMED06973602730672 EUDAMED
- Basic UDI-DI
- 697360273ION-T0KE EUDAMED
- Direct Marketing DI
- 06973602730658 EUDAMED06973602730672 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 — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232020 | Class I | Active |
| 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 (3)
- EUDAMED 9a1f848a-e298-473f-81e3-906702984ffd 61 fields · synced Oct 6, 2026
- EUDAMED 1b6c9cb0-2c49-4a7b-8f10-6f5767ce1eaa 61 fields · synced May 19, 2026
- FDA 510(k) K232020 1 fields · synced May 18, 2026