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VitalConnect, Inc.

USA · San Jose

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Singapore, Australia, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 3Class III 0

plus 3 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class II 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States3 registration records, 10 510(k), 0 PMA

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: VitalConnect, Inc. · VITAL CONNECT INC.

FDA 510(k) clearances by year

22014

12015 · K152139

22017 · K163453

22019 · K190916

22020 · K193343

12025 · K242129

FDA listed device types

Tape And Bandage, Adhesive 1Transmitters And Receivers, Physiological Signal, Radiofrequency 1Detector And Alarm, Arrhythmia 1Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242129	VitalRhythm	2025-04-17
US	K193343	Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)	2020-04-20
US	K192757	VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D Biosensor bag of 20	2020-02-06
CA	92484	VITALCONNECT PLATFORM	Class II

VitalConnect, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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