Identity
- Trade Name
- VX1 Application EUDAMED
- Device Name
- VX1 Application EUDAMED
- Model / Reference
- S001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770019196021 EUDAMED
- Basic UDI-DI
- B-03770019196021 EUDAMED
- EMDN Code
- Z12050792 INSTRUMENTS FOR CARDIOLOGICAL POLYGRAPHY - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
VX1 Application by Substrate Hd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03770019196021 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Substrate HD
- EUDAMED SRN
- FR-MF-000000507
Sources (1)
- EUDAMED d9cb47df-0470-4612-ac43-2b6a96797e6f 61 fields · synced Jun 18, 2026