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Cardiopulmonary bypass Heart Lung Machine(Essenz HLM ) - India CDSCO Medical Device Registration

Cardiopulmonary bypass Heart Lung Machine(Essenz HLM ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000715_ffa1a7cf0579642d06ddba5457c25571_ebfe7cd073e4b2fa4d81bbba03f6800d. This device is marketed under the brand name Stockert S5 Heart Lung Machine. The license holder is LIVANOVA INDIA PVT. LTD., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Cardiopulmonary bypass Heart Lung Machine(Essenz HLM )
UID: IMP/MD/2022/000715_ffa1a7cf0579642d06ddba5457c25571_ebfe7cd073e4b2fa4d81bbba03f6800d

Brand Name

Stockert S5 Heart Lung Machine

Device Class

Class C

Approving Authority

CDSCO

Product Information

Intended Use: The Essenz Heart-Lung Machine is intended for use for patients undergoing procedures requiring extracorporeal circulation. Intended Purpose: The Essenz Heart-Lung Machine is intended to perform, control, monitor and support extracorporeal blood circulation replacing the mechanical pumping function of the heart, monitoring and regulating physiologic parameters during procedures requiring extracorporeal circulation

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