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Blood Cell freeze and thaw system - India CDSCO Medical Device Registration

Blood Cell freeze and thaw system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000031_ba620a3cfce294cc9b391f2d47ed456d_2552c38e4eff43669cc118aad8fc82d1. This device is marketed under the brand name Haemonetics ACPยฎ 215. The license holder is SPAN HEALTHCARE PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Blood Cell freeze and thaw system
UID: IMP/MD/2023/000031_ba620a3cfce294cc9b391f2d47ed456d_2552c38e4eff43669cc118aad8fc82d1

Brand Name

Haemonetics ACPยฎ 215

Device Class

Class B

Approving Authority

CDSCO

Product Information

It is intended to be used for the preparation of collected red blood cell products with glycerol for freezing, the deglycerolization of thawed red blood cell products, removing extra cellular components, and resuspend the red blood cells in an additive solution and the washing of red blood cell units stored in commonly used AC and additive solutions to remove plasma and extra cellular components.

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