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Tyson Bioresearch, Inc.

✓ Record-verifiedregistrations found in 4 marketsEU SRN TW-MF-000027508

This company has registrations in European Union, United States, Brazil, Israel — 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

pendingnot queried

EUEuropean UnionEUDAMED

24UDI-DI device records

ivd-annex-ii-list-b 23ivd-devices-self-testing 1

USUnited StatesFDA openFDA

3listed device types

Class I 1Class II 2Class III 0

plus 5 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

1registered devices

Class I 1

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

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.

European Union24 raw hits, 0 excluded, 24 confirmed

United States5 registration records, 13 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: TYSON BIORESEARCH, INC.

Regulatory identity

EU manufacturer SRN: TW-MF-000027508
EU authorised representative: MDSS GmbH

Registration details (sample)

Market	Identifier	Name	Class / date
EU	D-T05H1690070KNQK	Rossmax	ivd-devices-self-testing
EU	04719869705938	Spengler JT100 Blood Glucose Test Strips (50T) (CE)	ivd-annex-ii-list-b
EU	04719869704115	JS100 Blood Glucose Monitoring System (Standard Plus) (CE)	ivd-annex-ii-list-b
EU	04719869704153	JS100 Blood Glucose Test Strips (50T) (CE)	ivd-annex-ii-list-b
US	K182046	Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System	2018-11-30
US	K182047	Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System	2018-11-29
US	K170079	Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System	2017-10-06
BR	80488329003	LANCETADOR TYSONBIO	Class I

Tyson Bioresearch, Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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