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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: D-KIT; D2-KIT; ICS 3000; Kainox VCS; Linox; Linoxsmart; PSW 1203.U/1; Renamic; Vigila; Volta
Classification Name: PROGRAMMER, PACEMAKER
Product Code: KRG
Device Class: 3
Regulation Number: 870.3700
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: Manufacturer
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