ESSEBI MEDICAL SRL TOTIM® 

Strada Campo del Fiume 84

47896 Faetano, RSM

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Phone: 0378 0549 963858

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• Declaration of Conformity MDR

• FDA- U.S. Food & Drug Administration

TOTIM Patient Cushion Immobilization System FDA 510(k) Cleared Class II - K 190894

• TOTIM Cleared China - Approval Date: 9 Dec, 2020 Reg No: 国械备20200697

• Japan Minister of Health, Labour and Welfare Medical Device

• Australian Government Department of Health Therapeutic Goods Administration