Identity
- Trade Name
- UI CUBE EUDAMED
- Device Name
- Electromagnetic Stimulator EUDAMED
- Model / Reference
- 0386 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809308380386 EUDAMED
- Basic UDI-DI
- 8809308380553AK EUDAMED
- Direct Marketing DI
- 08809308380386 EUDAMED
- EMDN Code
- Z120622 MUSCLE STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Ui Cube 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 Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8809308380553AK | Class IIa | Unknown |
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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 ec9eac6a-f570-4c80-85a5-4442bcd311d5 61 fields · synced Jun 18, 2026