Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
In vitro diagnostic medical devices
/
IVD instruments
/
Chemistry / immunochemistry instruments
/
Chemistry / immunochemistry rapid tests + poc tests
Chemistry / immunochemistry rapid tests + poc tests
W020106
681 devices
Subcategories
2
W02010601
Diabetes monitoring
410
devices
›
W02010690
Various rapid test chemistry / immunochemistry instruments ("point of care" and/or emergency)
271
devices
›
Devices
OneTouch Select Plus Flex
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
Novacheck Blood Glucose Meter (Glucometer)
Novatech Tibbi̇ Ci̇haz Ürünleri̇ Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
·
,
Türkiye
IVD Annex II List B
CE/IVDD
CLEVER CHECK TD-4125 Sistem pentru monitorizarea glicemiei
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Blood Glucose Meter
Cofoe Medical Technology Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
Safe AQ max Ⅲ
Changsha Sinocare Inc.
·
,
China
IVD Annex II List B
CE/IVDD
Soludiab
Tyson Bioresearch, Inc.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Blood Glucose Meter
Cofoe Medical Technology Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
Glucocard W (Gt-7210)
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
Blood Glucose Monitoring System
Bioland Technology Ltd.
·
,
China
IVD Annex II List B
FDA 510(k)
K202739
Active
Cleared 12 Aug 2022
CE/IVDD
saneo® SV-GD 01 Blood Glucose Meter
Eps Bio Technology Corp.
·
,
Taiwan
IVD for self-testing
CE/IVDD
Spengler JT100 Blood Glucose Monitoring System (CE)
Tyson Bioresearch, Inc.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing
OSANG HEALTHCARE Co., Ltd.
·
,
South Korea
IVD Annex II List B
CE/IVDD
On Call Sure Blood Glucose Meter
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
GlucoLeader Enhance Blood Glucose Monitoring System
Hmd Biomedical Inc.
·
,
Taiwan
IVD Annex II List B
FDA 510(k)
K182428
Active
Cleared 8 May 2019
CE/IVDD
Blood Glucose Meter
Bioland Technology Ltd.
·
,
China
Class C
CE/IVDR
V74 051313 0032
Active
Valid to Apr 2030
Blood Glucose Monitoring System
YASEE BioMedical Inc.
·
,
China
IVD Annex II List B
CE/IVDD
Solus V2 Blood Glucose Monitoring System
Ok Biotech Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
SOMA® be Self Monitoring Blood Glucose System
Eps Bio Technology Corp.
·
,
Taiwan
IVD for self-testing
CE/IVDD
Handheld electrochemical meter
Eaglenos Sciences, Inc.
·
,
China
Class A
CE
Handheld electrochemical meter
Eaglenos Sciences, Inc.
·
,
China
Class A
CE/IVDR
Previous
Next