Ultrafilter - India CDSCO Medical Device Registration

Ultrafilter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000430_d5f4209032a1a375ea300adac955330a_95a22347a5fb4dc136785d3ee1f3072e. 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

Ultrafilter

UID: IMP/MD/2021/000430_d5f4209032a1a375ea300adac955330a_95a22347a5fb4dc136785d3ee1f3072e

Brand Name

U9000 PLUS

License Holder

Baxter India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The U9000 Plus Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain microbiologically high quality dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized. The U9000 Plus Ultrafilter is intended to be used in conjunction with a water treatment system