Vx1

FDA UDI

Class II (US FDA UDI)

by Substrate Hd

Identity

Trade Name: VX1 FDA UDI
Generic Name: Cardiac mapping system computer FDA UDI
Device Name: Cardiac Electrophysiology mapping tool FDA UDI
Model / Reference: A001 FDA UDI
Description: Cardiac Electrophysiology mapping tool FDA UDI

Identifiers

Catalog Number: A001 FDA UDI
Primary DI / UDI-DI: 03770019196007 FDA UDI
510(k) Number: K201298 FDA UDI
FDA Product Code: DQK FDA UDI
GMDN Term: Cardiac mapping system computer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1425 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiac mapping system computer

Vx1 by Substrate Hd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac mapping system computer.

Change Healthcare Cardiology ECG Management — Change Healthcare Canada Company · Class II
Change Healthcare Cardiology ECG Management — Change Healthcare Canada Company · Class II
Globe® Workstation — Kardium, Inc. · Class II
GEMS Win TTM — CardioComm Solutions, Inc · Class II
Change Healthcare Cardiology ECG Management — Change Healthcare Canada Company · Class II
Ablamap® System — Ablacon Inc. · Class II
McKesson Cardiology ECG Management — Change Healthcare Canada Company · Class II
GEMS Win Air — CardioComm Solutions, Inc · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Substrate Hd

Sources (1)

FDA UDI 6c9241c4-6685-4b01-be76-90eff914aff8 36 fields · synced Jun 6, 2026