• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Establishment Registration & Device Listing

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
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
Classification Name: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Product Code: NKE
Device Class: 3
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
-
-