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Système de stimulation ExaStim®
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref EXA-001
by Aneuvo
Identity
- Trade Name
- Système de stimulation ExaStim® EUDAMED
- Device Name
- ExaStim Stimulation System EUDAMED
- Model / Reference
- EXA-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850053287121 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
- France 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
Système de stimulation ExaStim® by Aneuvo — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252893 | Class IIb | Active |
| 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 (2)
- EUDAMED d0724111-ebdc-46a0-897e-0430346ecc5c 61 fields · synced Jun 20, 2026
- FDA 510(k) K252893 1 fields · synced May 18, 2026