Embolization Microspheres - India CDSCO Medical Device Registration
Embolization Microspheres is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000367_70e69fa9ae2760082d5047440c3acbee_5fd1c0587bfcec94add8a79d903786aa. This device is marketed under the brand name EmboSphere MicroSpheres in vial. The license holder is M/s Merit Medical Systems India Pvt. Ltd.,, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
EmboSphere MicroSpheres in vial
License Holder
M/s Merit Medical Systems India Pvt. Ltd.,Device Class
Approving Authority
CDSCO
Product Information
Hepasphere Microspheres are indicated for use in the embolization of blood vessels with or without delivery of Doxorubicin HCI for therapeutic or pre-operative purposes in the following procedures: ? Embolization of hepatocellular carcinoma ? Embolization of metastases to the liver
Manifolds
Brand: Angiographic Tray
Customized Kits - 1(Merit Customs Kit - 1 )
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Customized Kits - 2(Merit Customs Kit - 2
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Aspiration Catheters
Brand: ASAP Aspiration Catheter Kit and ASAPLP Low Profile Aspiration Catheter Kit
Needles
Brand: Angiographic Tray
Inflation Devices and Kits(Basix Touch, Basix Compak )
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Customized Kits - 3(Merit Customs Kit - 3 )
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Custom Manifold Kit
Brand: Angiographic Tray
Sheath Introducer
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Microcatheter
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices