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VIVALNK, INC.

USA · Campbell

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia — 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

5listed device types

Class I 1Class II 4Class III 0

plus 7 registration records and 3 510(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

0active device licences

2 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

7active ARTG entries

Class I 3IIa 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States7 registration records, 3 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: VIVALNK, INC.

FDA 510(k) clearances by year

12017 · K162137

12018 · K181013

12020 · K191870

FDA listed device types

Oximeter 1Continuous Measurement Thermometer 1Transmitters And Receivers, Physiological Signal, Radiofrequency 1System, Measurement, Blood-Pressure, Non-Invasive 1Tape And Bandage, Adhesive 1

Market	Identifier	Name	Class / date
US	K191870	VV330 Continuous ECG Platform, VivaLNK Adhesive Patch	2020-01-07
US	K181013	Fever Scout	2018-08-21
US	K162137	Fever Scout Continuous Monitoring thermometer	2017-01-19

VIVALNK, 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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