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Electrical Stimulator / EMG IVES Pro
EUDAMEDClass IIa (EU MDR)
Ref －Model GD-6124
Identity
- Trade Name
- Electrical Stimulator / EMG IVES Pro EUDAMED
- Device Name
- Electrical Stimulator / EMG IVES Pro EUDAMED
- Model / Reference
- GD-6124 EUDAMED－ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571292661744 EUDAMED
- Basic UDI-DI
- 45712926617443Y EUDAMED
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMED
Classification
- Device Class
- Class IIa 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
Electrical Stimulator / EMG IVES Pro by OG Wellness Technologies Co., Ltd. Headquarters — 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 | 45712926617443Y | Class IIa | Active |
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Manufacturer
- Manufacturer
- OG Wellness Technologies Co., Ltd. Headquarters
- EUDAMED SRN
- JP-MF-000002613
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 4a6121ca-6ceb-46fe-815b-46bc1caa2492 61 fields · synced Jul 11, 2026