Biopsy Needles / Systems(Temno Devices ) - India CDSCO Medical Device Registration
Biopsy Needles / Systems(Temno Devices ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000388_9bd70da30352f83a070cdcb3d0a42ee9_13b04066ec5d2835d3178748143038b5. This device is marketed under the brand name High Pressure Tubing, Pressure Monitoring Tubing. The license holder is M/s Merit Medical Systems India Pvt. Ltd.,, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
High Pressure Tubing, Pressure Monitoring Tubing
License Holder
M/s Merit Medical Systems India Pvt. Ltd.,Device Class
Approving Authority
CDSCO
Product Information
Intended for use in obtaining core biopsy samples from soft tissue such as breast, kidney, liver, lung, thyroid, and various soft tissue masses. Not intended for use in bone
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

