PTCA Custom Kit - India CDSCO Medical Device Registration

PTCA Custom Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000042_e3a641d13226c26bef885309a0eb11e6_2874eff63129310cbb5de492b3b34d20. This device is marketed under the brand name Explorer. The license holder is Dolphin Lifescience India LLP, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class D

PTCA Custom Kit

UID: MFG/MD/2019/000042_e3a641d13226c26bef885309a0eb11e6_2874eff63129310cbb5de492b3b34d20

Brand Name

Explorer

License Holder

Dolphin Lifescience India LLP

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

PTCA Custom Kit is intended to use different accessories specified kit for use during PTCA and Angiography procedure for fluid and pressure management of the procedure. The Kits are multipurpose and each device has specific use during procedure

Class D

Brand: Asteria

Class C

Intra Aortic Balloon Catheter Kit

Class D

Angiographic Guide Wire

Brand: Explorer

Class D