Plasmafilter - India CDSCO Medical Device Registration

Plasmafilter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000430_9b4199b06c33da6826e28660c69a2f20_e6939fb05d575a8230f416d4c6f43437. This device is marketed under the brand name U9000 PLUS. The license holder is Baxter India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Plasmafilter

UID: IMP/MD/2021/000430_9b4199b06c33da6826e28660c69a2f20_e6939fb05d575a8230f416d4c6f43437

Brand Name

U9000 PLUS

License Holder

Baxter India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The PF 2000N plasmafilter is intended for use in therapeutic plasmafiltration, thus in diseases where removal of plasma components is indicated. It can also be used in plasmafiltration procedures where filtered plasma is reinfused. The size, weight, cardiac status and general physical condition of the patient must be evaluated by the prescribing physician before each treatment. The choice of the appropriate plasmafilter and associated equipment as well as the treatment operating parameters are the sole responsibility of the physician. special attention must be paid in connection with pediatric use. It is recommended that the plasmafilter is used together with a machine that complies with national or international standards