AfricaRegulatory
African Pharmaceutical Regulatory Intelligence
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Medical Divice in Zambia
33 products registered with ZAMRA — 33 active
| Brand / Product | Reg. No. | Holder | Status | Expires |
|---|---|---|---|---|
| Picterus® Jaundice Pro | ZAMRA-MDR-26-137 | Picterus AS | active | 8 Jul 2031 |
| Disposable Blood Lancets | ZAMRA-MDR-26-51 | Changsha Sinocare Inc. | active | 3 Apr 2031 |
| Lumira Dx D-Dimer Test Strips | ZAMRA-MDR-26-48 | Roche Diagnostics South Africa (Pty) Ltd | active | 3 Apr 2031 |
| Lumira DX | ZAMRA-MDR-26-49 | Roche Diagnostics South Africa (Pty) Ltd | active | 3 Apr 2031 |
| LumiraDx NT-proBNP | ZAMRA-MDR-26-47 | Roche Diagnostics South Africa (Pty) Ltd | active | 3 Apr 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. | ZAMRA-MDR-26-50 | Changsha Sinocare Inc. | active | 3 Apr 2031 |
| MyHealth app and compatible TeltoHeart smart wearable (the Watch App) | ZAMRA-MDR-26-33 | Teltonika Telemedic UAB | active | 3 Mar 2031 |
| MEGAHEAL | ZAMRA-MDR-26-14 | Aristo Pharmaceuticals Private Limited | active | 14 Feb 2031 |
| TRULAB QUATTRO | ZAMRA-MDR-26-10 | STRATTON LIFE SCIENCES LIMITED | active | 14 Feb 2031 |
| HemoCue Hb 201+ Analyzer Rub | 498/001L | MM African Technology Zambia | active | 21 Dec 2030 |
| HemoCue® WBC DIFF Analyser patch | 498/003L | MM African Technology Zambia | active | 9 Dec 2030 |
| HemoCue® HbA1c 501 | 498/004L | MM African Technology Zambia | active | 9 Dec 2030 |
| Hemocue Glucose 201 RT Analyser | 498/005L | MM African Technology Zambia | active | 9 Dec 2030 |
| SANIDEX OPA | ZAMRA-MDR-25-169 | SIRMAXO | active | 4 Oct 2030 |
| Ipas MVA Plus® Aspirator | ZAMRA-MDR-25-153 | WomanCare Global | active | 4 Oct 2030 |
| Ipas EasyGrip Cannulas | ZAMRA-MDR-25-02 | WomanCare Global | active | 14 Sept 2030 |
| Advanced Quality Rapid Anti-HCV Test | ZAMRA-MDR-25-120 | InTec PRODUCTS, INC. | active | 19 Aug 2030 |
| One Step Malaria (Pf) Test | ZAMRA-MDR-25-119 | InTec PRODUCTS, INC. | active | 19 Aug 2030 |
| ONE STEP Anti-HIV (1&2) Test | ZAMRA-MDR-25-121 | InTec PRODUCTS, INC. | active | 19 Aug 2030 |
| Accu-Chek Active Blood Glucose Monitoring System | 493/001L | Roche Diabetes Care South Africa (Pty) Ltd | active | 6 Aug 2030 |
| Accu-Chek Instant Kit | 493/004L | Roche Diabetes Care South Africa (Pty) Ltd | active | 6 Aug 2030 |
| Accu-Chek Active Test Strips | 493/003L | Roche Diabetes Care South Africa (Pty) Ltd | active | 6 Aug 2030 |
| ShangRing Male Circumcision Device with Removal Tool & Band Aïd | 386/001L | Pharm Access Africa Ltd | active | 28 Jul 2030 |
| Mothers of Africa - ANC Panel | ZAMRA-MDR-25-111 | C Centric Management (Pty) Ltd | active | 24 Jun 2030 |
| Thermalytix | ZAMRA-MDR-25-47 | Triage Healthcare | active | 15 Jan 2030 |
| AVISURE TYPHOID IgG/IgM Rapid Test Kit | ZAMRA-MDR-25-06 | Prime Pharmaceuticals Ltd | active | 4 Jan 2030 |
| NasoFaes Fluid + | ZAMRA-MDR-24-81 | FAES FARMA S.A. | active | 28 Nov 2029 |
| Nasofaes triple action + | ZAMRA-MDR-24-80 | FAES FARMA S.A. | active | 28 Nov 2029 |
| Wondfo HIV Self-Test | ZAMRA-MDR-24-64 | Guangzhou Wondfo Biotech Co.,Ltd. | active | 29 Sept 2029 |
| TB Tuberculosis Antibody Test Kit | ZAMRA-MDR-24-61 | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD | active | 13 Aug 2029 |
| HIV (1/2) Antibody Test Kit (Colloidal Gold) | ZAMRA-MDR-24-60 | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD | active | 13 Aug 2029 |
| Neisseria Gonorrhoeae Antigen Test Kit (Colloidal Gold) | ZAMRA-MDR-24-62 | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD | active | 13 Aug 2029 |
| TP Syphilis Antibody Test Kit | ZAMRA-MDR-24-59 | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD | active | 13 Aug 2029 |
Medical Divice — ZAMRA Registration Details
ZAMRA (Zambia) has 33 registered products containing Medical Divice, of which 33 are currently active. Data is sourced directly from the official ZAMRA drug register and refreshed daily.
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