Identity
- Trade Name
- BrainStim EUDAMED
- Device Name
- Transcranial Magnetic Stimulator EUDAMED
- Model / Reference
- 0614 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809308380614 EUDAMED
- Basic UDI-DI
- 8809308380195AF EUDAMED
- Direct Marketing DI
- 08809308380614 EUDAMED
- EMDN Code
- Z12101105 MAGNETIC STIMULATORS EUDAMED
Classification
- Device Class
- Class IIb 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
BrainStim by REMED Co., Ltd. — Class IIb — 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 | 8809308380195AF | Class IIb | 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 f68f6f51-03bc-4feb-b9e6-09df8701aee6 61 fields · synced Jun 20, 2026