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CDSCO UID IMP/MD/2019/000224_b63ed5b2326b395b2530b22689ba4551_1f15ce90cf71bdb785d3860e0ce6af63

PTCA Balloon Dilatation Catheter

Hester Diagnostics Pvt. Ltd., ,Office No. 213/214/214 A/215/216, Jolly Bhavan No. 1, 2nd Floor, 10, New Marine Lines, Taluka Marine Line, District Mumbai Zone1 ,Mumbai City Maharashtra ,400020 ,India·Device Class Class D·India CDSCO·Brand: IKAZUCHI Zero, Raiden 3
Registration details
UID
IMP/MD/2019/000224_b63ed5b2326b395b2530b22689ba4551_1f15ce90cf71bdb785d3860e0ce6af63
Device class
Class D
Brand name
IKAZUCHI Zero, Raiden 3
License holder
Hester Diagnostics Pvt. Ltd., ,Office No. 213/214/214 A/215/216, Jolly Bhavan No. 1, 2nd Floor, 10, New Marine Lines, Taluka Marine Line, District Mumbai Zone1 ,Mumbai City Maharashtra ,400020 ,India
Approving authority
CDSCO
Product information
This product is intended to be used for dilating the stenosis lesion in the coronary artery when performing percutaneous transluminal coronary angioplasty (IKAZUCHI Zero, Raiden 3).
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About this record

PTCA Balloon Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000224_b63ed5b2326b395b2530b22689ba4551_1f15ce90cf71bdb785d3860e0ce6af63. This device is marketed under the brand name IKAZUCHI Zero, Raiden 3. The license holder is Hester Diagnostics Pvt. Ltd., ,Office No. 213/214/214 A/215/216, Jolly Bhavan No. 1, 2nd Floor, 10, New Marine Lines, Taluka Marine Line, District Mumbai Zone1 ,Mumbai City Maharashtra ,400020 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

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