Dear partners, We would like to inform you that we have completed all the necessary technical, toxicological and clinical testing of iCheck-branded products and have also received a positive conclusion from the Federal Service for Surveillance in Healthcare concerning the following medical devices: “Consumables for the iCHECK Blood Glucose Meter,” Registration Certificate No. FSZ 2007/00507 dated 22 April 2020, and “iCHECK Blood Glucose Meter with Accessories,” Registration Certificate No. FSZ 2007/00506 dated 22 April 2020.
regarding adjustments to the packaging, design, instructions and labels.
NEW TRADE NAME OF THE MEDICAL DEVICE (MD) FOR THE RUSSIAN FEDERATION:
iCheck (in Russian only).
The change in the trade name applies to the entire set of accessories and consumables for the blood glucose meter to which the original name referred.
Due to the change in the trade name of the medical device, amendments will be made to the registration certificates for the medical devices.
NEW NAME:
Registration Certificate No. FSZ 2007/00507 dated 22 April 2020: “Consumables for the iCheck Blood Glucose Meter”;
Registration Certificate No. FSZ 2007/00506 dated 22 April 2020: “iCheck Blood Glucose Meter.”
NEW SPECIFICATIONS:
The iCheck Blood Glucose Meter does not require coding;
The coding strip is not included and has been removed from the blood glucose meter accessories;
The coding strip has been excluded from Registration Certificate No. FSZ 2007/00506 dated 22 April 2020 and Registration Certificate No. FSZ 2007/00507 dated 22 April 2020;
The control solution (2 vials) has been removed from the blood glucose meter accessories listed in Registration Certificate No. FSZ 2007/00506 dated 22 April 2020;
Blood sample volume required for testing: 0.9 µL;
Test strip storage period after first opening the vial: 120 days;
Test strip shelf life from the date of manufacture: 24 months.
We confirm that the absence of blood glucose meter coding, reduction in the blood sample volume required for testing, extension of the test strip storage period after first opening and extension of the test strip shelf life from the date of manufacture, as well as the change in the composition of the accessories, have not resulted in any changes to the properties and characteristics affecting the quality, performance or safety of the medical devices covered by Registration Certificate No. FSZ 2007/00507 dated 22 April 2020, “Consumables for the iCheck Blood Glucose Meter,” and Registration Certificate No. FSZ 2007/00506 dated 22 April 2020, “iCheck Blood Glucose Meter.”
regarding adjustments to the packaging, design, instructions and labels.
NEW TRADE NAME OF THE MEDICAL DEVICE (MD) FOR THE RUSSIAN FEDERATION:
iCheck (in Russian only).
The change in the trade name applies to the entire set of accessories and consumables for the blood glucose meter to which the original name referred.
Due to the change in the trade name of the medical device, amendments will be made to the registration certificates for the medical devices.
NEW NAME:
Registration Certificate No. FSZ 2007/00507 dated 22 April 2020: “Consumables for the iCheck Blood Glucose Meter”;
Registration Certificate No. FSZ 2007/00506 dated 22 April 2020: “iCheck Blood Glucose Meter.”
NEW SPECIFICATIONS:
The iCheck Blood Glucose Meter does not require coding;
The coding strip is not included and has been removed from the blood glucose meter accessories;
The coding strip has been excluded from Registration Certificate No. FSZ 2007/00506 dated 22 April 2020 and Registration Certificate No. FSZ 2007/00507 dated 22 April 2020;
The control solution (2 vials) has been removed from the blood glucose meter accessories listed in Registration Certificate No. FSZ 2007/00506 dated 22 April 2020;
Blood sample volume required for testing: 0.9 µL;
Test strip storage period after first opening the vial: 120 days;
Test strip shelf life from the date of manufacture: 24 months.
We confirm that the absence of blood glucose meter coding, reduction in the blood sample volume required for testing, extension of the test strip storage period after first opening and extension of the test strip shelf life from the date of manufacture, as well as the change in the composition of the accessories, have not resulted in any changes to the properties and characteristics affecting the quality, performance or safety of the medical devices covered by Registration Certificate No. FSZ 2007/00507 dated 22 April 2020, “Consumables for the iCheck Blood Glucose Meter,” and Registration Certificate No. FSZ 2007/00506 dated 22 April 2020, “iCheck Blood Glucose Meter.”
