Identity
- Trade Name
- ExaStim® Stimulationssystem EUDAMED
- Device Name
- ExaStim Stimulation System EUDAMED
- Model / Reference
- EXA-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850053287329 EUDAMED
- Basic UDI-DI
- 0850053287EXSYYU EUDAMED
- Direct Marketing DI
- 00850053287053 EUDAMED
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMED
Classification
- Device Class
- Class IIb 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
ExaStim® Stimulationssystem by Aneuvo — 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 | 0850053287EXSYYU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Aneuvo
- EUDAMED SRN
- US-MF-000041520
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 2a3bb9e0-3899-4697-9000-74a8ca4967d9 61 fields · synced Jul 30, 2026