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APEX BIOTECHNOLOGY CORP.

Taiwan·TW-MF-000019773

Last updated September 17, 2026

Information

Country
Taiwan
Address
No. 7, Li-Hsin Road V Hsinchu Science Park, Hsinchu, Taiwan, Hsinchu, Taiwan
Website
apexbio.com
LinkedIn
—
Facebook
—
Phone
+886 3 564 1952
PRRC Contact
Lisa Liu
EUDAMED SRN
TW-MF-000019773
FDA FEI Number
3002671736
DUNS Number
—

Catalogue (70)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
Ketosure Poc M032
EUDAMED
Class AActive
Eclipse PLUS M034
EUDAMED
Class AActive
Contrex Plus 6 S5800403 S5800404 S5800405
EUDAMED
IVD GeneralActive
KETOSURE POC base unit M033
EUDAMED
Class AActive
Eclipse PLUS S5641010 S5641011
EUDAMED
IVD GeneralActive
GlucoSure Autocode S5636096, S5640087, S5640249, S5640809, S5640259, S5636097, S5640088, S5640808, S5640751, S5640887, S5641016, S5641017
EUDAMED
IVD Annex II List BActive
MultiSure GCTU S81001, S81002
EUDAMED
IVD Annex II List BActive
Eclipse PLUS S35010
EUDAMED
IVD GeneralActive
Contrex Plus 5 S5800301 S5800303 S5800459 S5800460 S5800461
EUDAMED
IVD Annex II List BActive
Wellion AMADEUS S70522, S70523
EUDAMED
IVD Annex II List BActive
Ketosure Poc S5400044
EUDAMED
IVD GeneralActive
HemoSmart GOLD S25009, S25032, S25033
EUDAMED
IVD devices for self-testingActive
BGM014 Blood Glucose Monitoring System K182992
FDA 510(k)
Class IIActive
Autosure Voice 3 Plus Blood Glucose Monitoring System K120649
FDA 510(k)
Class IIActive
MultiSure GK Link Blood Glucose and Ketone Monitoring System K201880
FDA 510(k)
Class IIActive
GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System K142689
FDA 510(k)
Class IIActive
Autosure Voice Blood Glucose Monitoring System, Model As90011f9 K090043
FDA 510(k)
Class IIActive
GlucoSure HT Plus Blood Glucose Monitoring System K202885
FDA 510(k)
Class IIActive
Glucosure Blood Glucose Monitoring System K002621
FDA 510(k)
Class IIActive
Glucosure Star Blood Glucose Monitoring System, Model As90000e1 K073648
EUDAMEDFDA 510(k)
Class IIActive
MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System K143750
FDA 510(k)
Class IIActive
Meg-2b Blood Glucose Monitoring System, Pro Blood Glucose Monitoring System, Blood Glucose Test Strips, Glucose Control K120448
FDA 510(k)
Class IIActive
Contrex Plus Low Control Solution K100747
FDA 510(k)
Class IActive
Gal-1c Blood Glucose Monitoring System, Gal-1c Test Strips K102816
FDA 510(k)
Class IIActive
GAL-1A Plus Blood Glucose Monitoring System K213887
FDA 510(k)
Class IIActive
MTM301 Blood Glucose and Ketone Monitoring System K202534
FDA 510(k)
Class IIActive
KET-1 Blood Ketone Monitoring System K182593
FDA 510(k)
Class IActive
Meg-2 Blood Glucose Monitoring System, Meg-2 50's Test Strip, Meg-2 Control Solution K101204
FDA 510(k)
Class IIActive
Bgm009 Blood Glucose Monitoring System K141036
FDA 510(k)
Class IIActive
Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips K150396
FDA 510(k)
Class IIActive
GlucoSure Link Blood Glucose Monitoring System K212140
FDA 510(k)
Class IIActive
Autosure Ht Blood Glucose Monitoring System K131750
FDA 510(k)
Class IIActive
Gluco Track Blood Glucose Monitoring System K062799
FDA 510(k)
Class IIActive
Autosure Voice 3 Blood Glucose Monitoring System And Test Strip K102481
FDA 510(k)
Class IIActive
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System K220421
FDA 510(k)
Class IIActive
Modification To Glucosure Bgm System, Model 221100 K011233
FDA 510(k)
Class IIActive
Assure 4 Blood Glucose Monitoring System K070088
FDA 510(k)
Class IIActive
GlucoSure ADVANCE Link Blood Glucose Monitoring System K222234
FDA 510(k)
Class IIActive
Autosure Voice Ii Blood Glucose Monitoring System And Test Strips K102037
FDA 510(k)
Class IIActive
Glucosmart Blood Glucose Monitoring System K002624
FDA 510(k)
Class IIActive
Autosure Voice Ii Plus, Autosure Plus Blood Glucose Test Strips, Contrex Plus Iii K113098
FDA 510(k)
Class IIActive
Gal-1e Blood Glucose Monitoring System Gal-1e Blood Glucose Test Strips Gal-1e Multi Blood Glucose Monitoring System Gal K113547
FDA 510(k)
Class IIActive
Glucosure Voice Blood Glucose Monitoring System, Model As90011e1 K073137
FDA 510(k)
Class IIActive
BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System K161299
FDA 510(k)
Class IIActive
BGM009 Plus Blood Glucose Monitoring System K170267
FDA 510(k)
Class IIActive
Gal-1a Blood Glucose Monitoring System K113208
FDA 510(k)
Class IIActive
GlucoSure POC S84512, S84511
EUDAMED
IVD GeneralActive
GlucoSure Autocode S70123, S70488
EUDAMED
IVD Annex II List BActive
UASure II S95050, S95056, S95055, S95057
EUDAMED
IVD devices for self-testingActive
Contrex Plus III S5800091
EUDAMED
IVD Annex II List BActive

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FDA Establishments (1)

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

  • Apex Biotechnology Corp. US