Identity
- Trade Name
- Muscle Exerciser TOUCH FIT DUO EUDAMED
- Device Name
- Muscle Exerciser TOUCH FIT DUO EUDAMED
- Model / Reference
- GX-151 EUDAMED－ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571292661096 EUDAMED
- Basic UDI-DI
- 45712926610963G EUDAMED
- EMDN Code
- Z120603 PASSIVE REHABILITATIVE GYMNASTICS EQUIPMENT EUDAMED
Classification
- Device Class
- Class I 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
Muscle Exerciser TOUCH FIT DUO by OG Wellness Technologies Co., Ltd. Headquarters — 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 | 45712926610963G | Class I | 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 a69731e9-def6-448e-8b48-b60d8672b87c 61 fields · synced Jul 28, 2026