Balloon Inflation Devices - India CDSCO Medical Device Registration

Balloon Inflation Devices is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000463_9cff71bdb5fdb6516d87adc2ecfc3971_1261e89f8f1c8825ed3ddc5fbc05672a. 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 B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Balloon Inflation Devices

UID: IMP/MD/2020/000463_9cff71bdb5fdb6516d87adc2ecfc3971_1261e89f8f1c8825ed3ddc5fbc05672a

Brand Name

SHUNMEI

License Holder

SHUNMEI MEDICAL INDIA PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

Balloon inflation devices are intended to be used in PTCA operation, the balloon dilatation catheter is pressurized in order to achieve the expansion of blood vessels or the placement of intravascular stent. In minimally invasive balloon dilation procedure, the balloon inflation devices can be used to inflate the balloon with fluid, to monitor the pressure in the balloon during the procedure and to deflate the balloon after dilation

Class C

Introducer sets

Brand: SHUNMEI

SHUNMEI MEDICAL INDIA PRIVATE LIMITED

Class C

Brand: SHUNMEI

Class C