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tst biomedical electronics Co., Ltd.

Taiwan · Taoyuan · tst.bio

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

0UDI-DI device records

USUnited StatesFDA openFDA

7listed device types

Class I 6Class II 1Class III 0

plus 7 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

3registered devices

Class II 3

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.

European Union8,653 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

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

United Kingdom0 confirmed, 5 excluded

Brazil3 confirmed, 4 excluded

Manufacturer names merged into this page: TST BIOMEDICAL ELECTRONICS CO., LTD.

FDA listed device types

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl 1Analyzer, Chemistry, Centrifugal, For Clinical Use 1Apolipoproteins 1System, Test, Lipoprotein(A) 1Enzymatic Esterase--Oxidase, Cholesterol 1Analyzer, Chemistry, Micro, For Clinical Use 1Albumin, Antigen, Antiserum, Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80464810934	iProtin Reader (versão BT)	Class II
BR	80464810935	iProtin Lipoprotein(a) Assay Cartridge Kit	Class II
BR	80464810936	iProtin Apolipoprotein B Assay Cartridge Kit	Class II

tst biomedical electronics Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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