Identity
- Trade Name
- Gymna-Uniphy EUDAMED
- Device Name
- Medical Device Accessory EUDAMED
- Model / Reference
- OTH-01-01A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872332343 EUDAMED
- Basic UDI-DI
- 471987233OTHRH EUDAMED
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Gymna-Uniphy by ZMI Electronics 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 | 471987233OTHRH | Class I | Active |
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Manufacturer
- Manufacturer
- ZMI Electronics Ltd.
- EUDAMED SRN
- TW-MF-000003571
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED d27eee57-201e-4fa4-a520-f7eeb436bd1e 61 fields · synced Jun 18, 2026