Listed Home-use Blood Glucose Meters and Test Strips under MDACS

Listed Home-use Blood Glucose Meters and Test Strips under MDACS

The Medical Device Division (MDD) has granted listing approval for the following Home-use Blood Glucose Meters and Test Strips. All the listed devices meet the listing requirements of Medical Device Administrative Control System (MDACS) on safety, quality and performance. Department of Health has always been closely monitoring safety alerts of medical device issued by other regulatory jurisdictions as well as the World Health Organization, under the established mechanism, and handles adverse events associated with devices listed under MDACS.

Please refer to The List of Medical Devices for details of listed Home-use Blood Glucose Meters and Test Strips.

Listed Home-use Blood Glucose Meters and Test Strips under MDACS
Listing No.
(HKMD No.)		 Manufacturer Brand Name and Model Local Responsible Person Package
230200 Ascensia Diabetes Care Holdings AG CONTOUR PLUS ONE blood glucose monitoring system, CONTOUR PLUS ONE blood glucose meter, CONTOUR PLUS blood glucose test strips, CONTOUR PLUS controls Ascensia Diabetes Care Hong Kong Limited Package 1
Package 2
Package 3
Package 4
Package 5
Package 6
230201 Ascensia Diabetes Care Holdings AG CONTOUR PLUS ELITE blood glucose monitoring system, CONTOUR PLUS ELITE blood glucose meter, CONTOUR PLUS blood glucose test strips, CONTOUR PLUS controls Ascensia Diabetes Care Hong Kong Limited Package 1
Package 2
Package 3
Package 4
Package 5
Package 6
230202 Ascensia Diabetes Care Holdings AG CONTOUR PLUS blood glucose monitoring system, CONTOUR PLUS blood glucose meter, CONTOUR PLUS blood glucose test strips, CONTOUR PLUS controls Ascensia Diabetes Care Hong Kong Limited Package 1
Package 2
Package 3
Package 4
Package 5
Package 6
220407 Ascensia Diabetes Care Holdings AG CONTOUR TS blood glucose monitoring system, CONTOUR TS blood glucose meter, CONTOUR TS blood glucose test strips, CONTOUR TS controls Ascensia Diabetes Care Hong Kong Limited Package 1
Package 2
Package 3
Package 4
Package 5
Package 6
Package 7
210083 Bionime Corporation GE100 Blood Glucose Monitoring System, GE100 Blood Glucose Test Strip Kingsford Far East Limited Package 1
Package 2
Package 3
Package 4
Package 5
Package 6
Package 7
Package 8
Package 9
Package 10
Package 11
Package 12
200114 Bionime Corporation Rightest GM700SB Leon Medical Supplies Limited Package 1
Package 2
Package 3
Package 4
200533 Roche Diabetes Care GmbH Accu-Chek Guide mmol/L blood glucose meter (07400969023), Accu-Chek Guide mmol/L Set (07400934020) Roche Diagnostics (Hong Kong) Limited Package 1
Package 2
200532 Roche Diabetes Care GmbH Accu-Chek Guide test strips (07453710020, 07453736020, 07453744020) Roche Diagnostics (Hong Kong) Limited Package 1
Package 2
Package 3
230039 Roche Diabetes Care GmbH Accu-Chek Performa test strips (06454003020, 06454011020, 06454038020) Roche Diagnostics (Hong Kong) Limited Package 1
Package 2
Package 3
Package 4
Package 5
Package 6
Package 7
Package 8
Package 9
Package 10
Package 11
Package 12
Package 13
Package 14
Package 15
Package 16
Package 17
Package 18


Last update on 28 March 2024

More:
Public Education on Home-use Blood Glucose Meters and Test StripsSafety Alerts & Special Alerts Related To Blood Glucose Meters and Test StripsTraders’ Corner: Application For Listing Of Home-use Blood Glucose Meters and Test Strips under MDACS