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.
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