Identity
- Trade Name
- Electrical Stimulator AUDIOTRON EUDAMED
- Device Name
- Electrical Stimulator AUDIOTRON EUDAMED
- Model / Reference
- EF-160 EUDAMED－ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571292660938 EUDAMED
- Basic UDI-DI
- B-04571292660938 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Electrical Stimulator AUDIOTRON by OG Wellness Technologies Co., Ltd. Headquarters — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04571292660938 | 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 01c21f6f-95e5-46c9-8206-1692cb6bdc70 61 fields · synced Jun 18, 2026