EUS Needle - India CDSCO Medical Device Registration

EUS Needle is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000198_c38e66b7f95283bcb5d204929d7c26ce_61de74174e747e0a255aaef38ec1fd07. This device is marketed under the brand name BIOPEG/INDOVASIVE. The license holder is Biorad Medisys Pvt Ltd, and it is classified as Device Class Class B. The approving authority is Pune Division.

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CDSCO Registered

Class Class B

EUS Needle

UID: MFG/MD/2023/000198_c38e66b7f95283bcb5d204929d7c26ce_61de74174e747e0a255aaef38ec1fd07

Brand Name

BIOPEG/INDOVASIVE

License Holder

Biorad Medisys Pvt Ltd

Device Class

Class B

Approving Authority

Pune Division

Product Information

The Endoscopic Ultra Sound Needle Aspiration System is used to sample targeted mucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope. This device is intended to be used with an ultrasound endoscope for delivery of injectable materials into tissues during endoscopic procedures and fine needle aspirations (BIOPEG/INDOVASIVE) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract

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Gastro Loop Basket

Brand: BIOPEG/INDOVASIVE

Biorad Medisys Pvt Ltd

EUS Needle - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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