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
/
Various rapid test chemistry / immunochemistry instruments ("point of care" and/or emergency)
/
Various rapid test chemistry / immunochemistry instruments - other
Various rapid test chemistry / immunochemistry instruments - other
W0201069099
235 devices
Hand-Held Immunofluorescence
Healgen Scientific Limited Liability Company
·
,
United States
Class A
CE/IVDR
Qassay Lateral Flow Reader DUAL
P4Q Health S.L.
·
,
Spain
Class A
CE/IVDR
FIA Analyzer BIOT-YG-I
Xiamen Biotime Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
Fluorescence Immunoassay Analyzer
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class A
CE/IVDR
Colloidal gold immunochromatography reader
Suzhou Helmen Precision Insturments Co., Ltd
·
,
China
Class A
CE/IVDR
Mission Cholesterol Meter
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Mission Ultra Cholesterol Meter
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
FIAPro™ Immunofluorescence Analyzer
Vitrosens Biotechnology Inc.
·
,
Türkiye
Class A
CE/IVDD
CE/IVDR
Colloidal gold immunochromatography reader
Suzhou Helmen Precision Insturments Co., Ltd
·
,
China
Class A
CE/IVDR
STANDARD™ F2400 Analyzer
Sd Biosensor, Inc.
·
,
South Korea
Class A
CE/IVDR
BeneCheck Prime Multi-Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
ENNOLIFE Clinical Chemistry Analyzer (Non-sterile)
ProtectLife International Biomedical Inc.
·
,
Taiwan
Class A
CE/IVDR
Afinion 2
Abbott Diagnostics Technologies AS
·
,
Norway
Class A
FDA 510(k)
K214117
Active
Cleared 27 Sep 2023
CE/IVDR
Hemoglobin Test Meter
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class A
CE/IVDR
Colloidal Gold & Fluorescence Analyzer
Coei Biotech Co.Ltd.
·
,
China
Class A
CE/IVDR
GENSPEED R2 Analyzer
GENSPEED Biotech
·
,
Austria
Class A
CE/IVDR
Uric Acid Meter
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
Class A
CE/IVDR
Test Kaseti̇-1 (62’LİK)
Vitrosens Biotechnology Inc.
·
,
Türkiye
Class A
CE/IVDR
Multiplex Fluorescent Analyzer
Healgen Scientific Limited Liability Company
·
,
United States
Class A
CE/IVDR
Blood Glucose and β-Ketone Test Meter
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class A
CE/IVDR
Previous
Next