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TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.

Taiwan · Taipei City

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 0Class II 6Class 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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

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: TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.

FDA 510(k) clearances by year

12017

32019 · K191207

12020 · K202497

12022 · K203208

12024 · K240220

22025 · K233963

FDA listed device types

System, Network And Communication, Physiological Monitors 1Oximeter 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Continuous Measurement Thermometer 1Monitor, Temperature, Dialysis 1Transmitters And Receivers, Physiological Signal, Radiofrequency 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233963	Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)	2025-02-25
US	K233956	Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)	2025-01-30
US	K240220	Aulisa Temperature Module (TM0002)	2024-09-27

TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, 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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