Endoscopic Ultrasound Needle - India CDSCO Medical Device Registration
Endoscopic Ultrasound Needle is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000236_8411f8a4fc1f555760ef417e3c6dc9f7_1bc3ae969c49e51efad4aaec02759563. The license holder is Glowtronics Private Limited, and it is classified as Device Class Class B. The approving authority is Karnataka.
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License Holder
Glowtronics Private LimitedDevice Class
Approving Authority
Karnataka
Product Information
EUS device is used to sample targeted sub-mucosal & extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope. EUS Needle is used with an ultrasound endoscope for fine needle biopsy of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract
