Balloon Dilatation Catheter - India CDSCO Medical Device Registration

Balloon Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000463_16eb53f14e746dc332d80db12a830d7a_fb98be300487e0d2451290e807d1c71c. This device is marketed under the brand name SHUNMEI. The license holder is SHUNMEI MEDICAL 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

Balloon Dilatation Catheter

UID: IMP/MD/2020/000463_16eb53f14e746dc332d80db12a830d7a_fb98be300487e0d2451290e807d1c71c

Brand Name

SHUNMEI

License Holder

SHUNMEI MEDICAL INDIA PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

The PTCA balloon dilatation catheter is intended for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The NC coronary dilatation catheter is intended for balloon dilatation of stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, and is also indicated for balloon dilatation of a coronary occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction and used for balloon dilatation of stent after implantation

Class B

Dose Control Syringe

Brand: SHUNMEI

SHUNMEI MEDICAL INDIA PRIVATE LIMITED

Class B

Brand: SHUNMEI

Class C