Identity
- Trade Name
- COMPACT-II EUDAMED
- Device Name
- Electromagnetic Stimulator EUDAMED
- Model / Reference
- 0379 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809308380379 EUDAMED
- Basic UDI-DI
- 8809308380553AK EUDAMED
- Direct Marketing DI
- 08809308380379 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
Compact-Ii 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 | 8809308380553AK | 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 38d14091-b591-4568-a265-da16b73f97ca 61 fields · synced Jun 19, 2026