Identity
- Trade Name
- Volta AF-Xplorer EUDAMEDFDA UDI
- Generic Name
- Cardiac mapping system computer FDA UDI
- Device Name
- Volta AF-Xplorer EUDAMEDCardiac Electrophysiology mapping tool FDA UDI
- Model / Reference
- A002 EUDAMEDFDA UDI
- Description
- Cardiac Electrophysiology mapping tool FDA UDI
Identifiers
- Catalog Number
- A002 FDA UDI
- Primary DI / UDI-DI
- 03770019196038 EUDAMEDFDA UDI
- Basic UDI-DI
- 3770019196A002RL EUDAMED
- Direct Marketing DI
- 03770019196038 EUDAMED
- 510(k) Number
- K223516 FDA UDI
- FDA Product Code
- DQK FDA UDI
- EMDN Code
- Z12050703 POLYGRAPHY SYSTEMS FOR ELECTROPHYSIOLOGICAL STUDIES EUDAMED
- GMDN Term
- Cardiac mapping system computer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1425 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Volta AF-Xplorer by Substrate Hd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3770019196A002RL | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Substrate HD
- EUDAMED SRN
- FR-MF-000000507
Sources (2)
- EUDAMED a8c00992-bcb8-49fb-9056-b9825b3ef11e 61 fields · synced Jul 11, 2026
- FDA UDI 6b6e00d2-8fcf-47b1-a59a-a4306510cdbc 36 fields · synced May 30, 2026