| All EU countries |
CE mark |
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| USA |
FDA under 510(k) - Sepax is the first automated technology to have such clearance. |
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| Argentina |
National Administration of Drugs, Foodstuffs and Medical Technology (ANMAT) |
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| Australia |
Australian Register Therapeutic Goods (ARTG), Therapeutic Good Administration (TGA) |
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| Brasil |
Brasilian National Health Vigilance Agency (ANVISA) |
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| Canada |
Canadian Medical Conformity Assessment System (CMDCAS) |
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| Israel |
Israel's Ministry of Health (IMOH) |
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| Japan |
Ministry of Health, Labor and Welfare (MHLW) |
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| Mexico |
Secretariat of Health |
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| Russia |
Russian Ministry of Health and the State Committee for Standardization, Metrology and Certification (Gosstandart) |
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| South Korea |
Korea Food & Drug Administration (KFDA) |
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| Taïwan |
Department of Health (DOH) |
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| Thailand |
Medical Device Control Division, Thai Food & Drug Administration (Thai FDA), Ministry of Public Health |
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