Identity
- Trade Name
- Volta AF-Xplorer II EUDAMED
- Device Name
- Volta AF-Xplorer II EUDAMED
- Model / Reference
- A003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770019196069 EUDAMED
- Basic UDI-DI
- 3770019196A003RN EUDAMED
- Direct Marketing DI
- 03770019196069 EUDAMED
- EMDN Code
- Z12050703 POLYGRAPHY SYSTEMS FOR ELECTROPHYSIOLOGICAL STUDIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
Volta AF-Xplorer II by Substrate Hd — 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 | 3770019196A003RN | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Substrate HD
- EUDAMED SRN
- FR-MF-000000507
Sources (1)
- EUDAMED 8c406db2-1ef4-47f4-8948-c0da2b9fcac1 61 fields · synced Jul 30, 2026