Capillary dialyzer - India CDSCO Medical Device Registration

Capillary dialyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000430_e5abfe4bdc58581192469bf5d0cbd262_87823041d565f952aeeba6b90ea74137. 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

Capillary dialyzer

UID: IMP/MD/2021/000430_e5abfe4bdc58581192469bf5d0cbd262_87823041d565f952aeeba6b90ea74137

Brand Name

U9000 PLUS

License Holder

Baxter India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Theralite dialyzer is only intended to be used for blood purification in hemodialysis mode in diseases where removal of plasma components with molecular weights up to a value of 45 kDa is indicated. The Theralite dialyzer is intended to be used in hemodialysis mode on monitors with controlled ultrafiltration.