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Sistema de estimulación ExaStim
EUDAMEDClass IIb (EU MDR)
Ref EXA-001
by Aneuvo
Identity
- Trade Name
- Sistema de estimulación ExaStim EUDAMED
- Device Name
- ExaStim Stimulation System EUDAMED
- Model / Reference
- EXA-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850053287114 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
- Spain 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
Sistema de estimulación ExaStim 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 bf01e6ad-4662-4203-ac76-3e545d1ab5ce 61 fields · synced Jul 9, 2026