Identity
- Trade Name
- ZTone EUDAMED
- Device Name
- Electromagnetic Stimulator EUDAMED
- Model / Reference
- 0492 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809308380492 EUDAMED
- Basic UDI-DI
- 8809308380492AQ EUDAMED
- Direct Marketing DI
- 08809308380492 EUDAMED
- EMDN Code
- Z120622 MUSCLE STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
ZTone by REMED Co., Ltd. — 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 | 8809308380492AQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- REMED Co., Ltd.
- EUDAMED SRN
- KR-MF-000008128
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED a09e577f-b4d4-442b-9129-4cc5be2c9737 61 fields · synced Jun 19, 2026