AfricaRegulatory

African Pharmaceutical Regulatory Intelligence

Medical Divice

33 registrations across 1 African market— 33 active

Markets with Medical Divice

Recent registrations

Brand / ProductMarketHolderStatusExpires
Picterus® Jaundice Pro🇿🇲ZambiaPicterus ASactiveJul 2031
Lumira Dx D-Dimer Test Strips🇿🇲ZambiaRoche Diagnostics South Africa (Pty) LtdactiveApr 2031
Disposable Blood Lancets🇿🇲ZambiaChangsha Sinocare Inc.activeApr 2031
Hemoglobin Monitoring System, includes H101 hemoglobin analyzer, H101 hemoglobin test strip, H102 Air hemoglobin analyzer, H102 hemoglobin test strip, and Sinocare hemoglobin control solution.🇿🇲ZambiaChangsha Sinocare Inc.activeApr 2031
LumiraDx NT-proBNP🇿🇲ZambiaRoche Diagnostics South Africa (Pty) LtdactiveApr 2031
Lumira DX🇿🇲ZambiaRoche Diagnostics South Africa (Pty) LtdactiveApr 2031
MyHealth app and compatible TeltoHeart smart wearable (the Watch App)🇿🇲ZambiaTeltonika Telemedic UABactiveMar 2031
MEGAHEAL🇿🇲ZambiaAristo Pharmaceuticals Private LimitedactiveFeb 2031
TRULAB QUATTRO🇿🇲ZambiaSTRATTON LIFE SCIENCES LIMITEDactiveFeb 2031
HemoCue Hb 201+ Analyzer
Rub
🇿🇲ZambiaMM African Technology ZambiaactiveDec 2030
HemoCue® HbA1c 501🇿🇲ZambiaMM African Technology ZambiaactiveDec 2030
HemoCue® WBC DIFF Analyser
patch
🇿🇲ZambiaMM African Technology ZambiaactiveDec 2030
Hemocue Glucose 201 RT Analyser🇿🇲ZambiaMM African Technology ZambiaactiveDec 2030
SANIDEX OPA🇿🇲ZambiaSIRMAXOactiveOct 2030
Ipas MVA Plus® Aspirator🇿🇲ZambiaWomanCare GlobalactiveOct 2030
Ipas EasyGrip Cannulas🇿🇲ZambiaWomanCare GlobalactiveSept 2030
ONE STEP Anti-HIV (1&2) Test🇿🇲ZambiaInTec PRODUCTS, INC.activeAug 2030
Advanced Quality Rapid Anti-HCV Test🇿🇲ZambiaInTec PRODUCTS, INC.activeAug 2030
One Step Malaria (Pf) Test🇿🇲ZambiaInTec PRODUCTS, INC.activeAug 2030
Accu-Chek Instant Kit🇿🇲ZambiaRoche Diabetes Care South Africa (Pty) LtdactiveAug 2030
Accu-Chek Active Blood Glucose Monitoring System🇿🇲ZambiaRoche Diabetes Care South Africa (Pty) LtdactiveAug 2030
Accu-Chek Active Test Strips🇿🇲ZambiaRoche Diabetes Care South Africa (Pty) LtdactiveAug 2030
ShangRing Male Circumcision Device with Removal Tool & Band Aïd🇿🇲ZambiaPharm Access Africa LtdactiveJul 2030
Mothers of Africa - ANC Panel🇿🇲ZambiaC Centric Management (Pty) LtdactiveJun 2030
Thermalytix🇿🇲ZambiaTriage HealthcareactiveJan 2030
AVISURE TYPHOID IgG/IgM Rapid Test Kit🇿🇲ZambiaPrime Pharmaceuticals LtdactiveJan 2030
NasoFaes Fluid +🇿🇲ZambiaFAES FARMA S.A.activeNov 2029
Nasofaes triple action +🇿🇲ZambiaFAES FARMA S.A.activeNov 2029
Wondfo HIV Self-Test🇿🇲ZambiaGuangzhou Wondfo Biotech Co.,Ltd.activeSept 2029
TP Syphilis Antibody Test Kit🇿🇲ZambiaANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDactiveAug 2029
Neisseria Gonorrhoeae Antigen Test Kit (Colloidal Gold)🇿🇲ZambiaANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDactiveAug 2029
TB Tuberculosis Antibody Test Kit🇿🇲ZambiaANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDactiveAug 2029
HIV (1/2) Antibody Test Kit (Colloidal Gold)🇿🇲ZambiaANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDactiveAug 2029

Medical Divice in Africa — Regulatory Overview

Medical Divice is registered across 1 African markets with 33 total product registrations on file. Data is sourced directly from official national drug regulatory authorities including Zambia. AfricaRegulatory refreshes this data daily from official government sources.

Of the 33 registrations, 33 (100%) are currently active. Regulatory affairs teams use AfricaRegulatory to track registration expiry dates, identify market incumbents, and monitor approval status across African markets without manual monitoring of each national regulator.