Identity
- Trade Name
- VX1 Hardware EUDAMED
- Device Name
- VX1 Hardware EUDAMED
- Model / Reference
- H001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770019196014 EUDAMED
- Basic UDI-DI
- 3770019196H001T3 EUDAMED
- Direct Marketing DI
- 03770019196014 EUDAMED
- EMDN Code
- Z1205078099 INSTRUMENTS FOR CARDIOLOGICAL POLYGRAPHY - HARDWARE ACCESSORIES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
VX1 Hardware by Substrate Hd — Class I — 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 | 3770019196H001T3 | Class I | Active |
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Manufacturer
- Manufacturer
- Substrate HD
- EUDAMED SRN
- FR-MF-000000507
Sources (1)
- EUDAMED b2494328-79a0-4f88-9841-133cf38750d1 61 fields · synced Jul 9, 2026