Non-Compliant PTCA Balloon catheter - India CDSCO Medical Device Registration

Non-Compliant PTCA Balloon catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000362_90a0af8c346c7d0c1b0078d10ed3c358_30a78b6b61bdbd11f0ed03a61f47878b. This device is marketed under the brand name Trans Wire-Prime. The license holder is Microtrol Sterilisation Services Pvt Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered

Class Class D

Non-Compliant PTCA Balloon catheter

UID: MFG/MD/2021/000362_90a0af8c346c7d0c1b0078d10ed3c358_30a78b6b61bdbd11f0ed03a61f47878b

Brand Name

Trans Wire-Prime

License Holder

Microtrol Sterilisation Services Pvt Ltd.

Device Class

Class D

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

Balloon dilation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial reperfusion and also used for post-dilation of stents