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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Paradym DR 8550; Paradym RF DR 9550; Paradym RF VR 9250; Paradym VR 8250
Classification Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Product Code: MRM
Device Class: 3
Registered Establishment Name: Sorin Group Italia Srl - CRM facility
Registered Establishment Number: 1000165971
Owner/Operator: SORIN BIOMEDICA CRM, S.R.L.
Owner/Operator Number: 9059364
Establishment Operations: Manufacturer; Repackager/Relabeler
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