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Sotera Wireless, Inc.

USA · San Diego

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Singapore — 4 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

11listed device types

Class I 1Class II 10Class III 0

plus 9 registration records and 9 510(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

1 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States9 registration records, 9 510(k), 0 PMA

Manufacturer names merged into this page: SOTERA WIRELESS · SOTERA WIRELESS, INC.

FDA 510(k) clearances by year

22012 · K122036

22013 · K133586

42015 · K152341

12018 · K180472

FDA listed device types

showing 8 of 11

System, Network And Communication, Physiological Monitors 1Detector And Alarm, Arrhythmia 1System, Measurement, Blood-Pressure, Non-Invasive 1Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Oximeter, Tissue Saturation 1Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) 1Oximeter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K180472	ViSi Mobile Monitoring System	2018-06-19
US	K152341	ViSi Mobile Monitoring System	2015-12-14
US	K142827	Visi Mobile Monitoring System, Visi Mobile Chest Sensor	2015-07-20

Sotera Wireless, 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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