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TYSON BIORESEARCH, INC.

Taiwan·TW-MF-000027508

Last updated September 17, 2026

Information

Country
Taiwan
Address
5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township,, Miaoli County, Taiwan
Website
tysonbio.com
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Roger Lee
EUDAMED SRN
TW-MF-000027508
FDA FEI Number
3003132490
DUNS Number
—

Catalogue (33)

DeviceModel / ReferenceRegistriesClassStatus
TysonBio AC500 Control Solution (Level 3) AC500
FDA UDI
Class IIActive
Tyson Bio HT100 Control Solution Level 3 HT100
FDA UDI
Class IIActive
Tyson Bio 50H Blood Glucose Test Strip, 50T Tyson Bio 50H
FDA UDI
Class IIActive
Tyson Bio HT100-B Blood Glucose Monitoring System HT100-B
FDA UDI
Class IIActive
plusMED fasTTest pM-100
EUDAMED
IVD Annex II List BActive
Spengler JT100 Blood Glucose Monitoring System (CE) JT100
EUDAMED
IVD Annex II List BActive
Spengler TB100 745012
EUDAMED
IVD Annex II List BActive
Tysonbio Md100 Blood Glucse Monitoring , Tysonbio Md100 Pro Blood Glucise Monitoring System K112916
FDA 510(k)
Class IIActive
Diachex+determine Blood Glucose Monitoring System, Diachex-Infinity Blood Glucose Monitoring System K073492
FDA 510(k)
Class IIActive
Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System K182047
FDA 510(k)
Class IIActive
Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System K182046
FDA 510(k)
Class IIActive
Ez Scan Plus Blood Glucose Monitoring System K072441
FDA 510(k)
Class IIActive
Ez Smart-168 Glucose Monitoring System K052818
FDA 510(k)
Class IIActive
Diachex Basic Blood Glucose Monitoring System, Diachex Superb Blood Glucose Monitoring System K072854
FDA 510(k)
Class IIActive
Tysonbio Link Health Management System K081726
FDA 510(k)
Class IIActive
Tysonbio Ac500, Ac800 Blood Glucose Monitoring System, Tysonbio Ac500 Ac800 Pro Blood Glucose Monitoring System K123087
FDA 510(k)
Class IIActive
Tysonbio Blood Glucose Monitoring System, Models Ac100 And Ac200 K101543
FDA 510(k)
Class IIActive
Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System K170079
FDA 510(k)
Class IIActive
Diachex Blood Glucose Monitoring System K062829
FDA 510(k)
Class IIActive
Easy Step And Diachex+ Pro Blood Glucose Monitoring Systems K090629
FDA 510(k)
Class IIActive
Spengler JT100 Control Solution (Level 2) (CE) JT100
EUDAMED
IVD Annex II List BActive
plusMED fasTTest pM-100_CS_Low
EUDAMED
IVD Annex II List BActive
Spengler JT100 Blood Glucose Test Strips (50T) (CE) JT100
EUDAMED
IVD Annex II List BActive
Spengler TB100 745000
EUDAMED
IVD Annex II List BActive
plusMED fasTTest pM-100_CS_High
EUDAMED
IVD Annex II List BActive
Soludiab BRLMV‐BT‐01
EUDAMED
IVD Annex II List BActive
Soludiab SCLMV-BT
EUDAMED
IVD Annex II List BActive
JS100 Blood Glucose Test Strips (50T) (CE) JS100
EUDAMED
IVD Annex II List BActive
Soludiab LGLMV-02
EUDAMED
IVD Annex II List BActive
Rossmax BGM_KIT_004_RM
EUDAMED
IVD devices for self-testingActive
Rossmax BGM_TS_001_RM
EUDAMED
IVD Annex II List BActive
Rossmax BGM_KIT_001_RM
EUDAMED
IVD Annex II List BActive
JS100 Blood Glucose Monitoring System (Standard Plus) (CE) JS100
EUDAMED
IVD Annex II List BActive

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Notified Bodies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Tyson Bioresearch Inc. US