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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: CardioMessenger; Dextrus; Ecuro; EDP; Effecta; EFH; Eluna; Entovis; Estella; Etrinsa; Evia; Home Monitoring; ICS 3000; Model 3145; Model 3150; Model 3171; Model 3175; Model 6646; Model 6652; Model 6653; P-KIT; Probetection; PSW 1203.U/1; PSW 1301.U; PSW 1304.U; PSW 1306.U; PSW 1307.U; Reliaty; Renamic; Reocor; Safio S; Selox; Setrox S; SLX; Solox; Tilda
Product Code: DTB
Device Class: 3
Regulation Number: 870.3680
Medical Specialty: Cardiovascular
Registered Establishment Name: BIOTRONIK SE & CO. KG
Registered Establishment Number: 9610139
Owner/Operator: BIOTRONIK SE & CO. KG
Owner/Operator Number: 9018331
Establishment Operations: Foreign Exporter; Manufacturer; Specification Developer