Sphinctrotome-Sphinctrotome - India CDSCO Medical Device Registration

Sphinctrotome-Sphinctrotome is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000036_b3a43a7bfe4e1100e8888436f6235e6f_cf6c9fd936a7ad7bc206ef5958d1cbc4. The license holder is Endo-Med Technologies Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Uttar Pradesh.

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CDSCO Registered

Class Class B

Sphinctrotome-Sphinctrotome

UID: MFG/MD/2021/000036_b3a43a7bfe4e1100e8888436f6235e6f_cf6c9fd936a7ad7bc206ef5958d1cbc4

License Holder

Endo-Med Technologies Pvt. Ltd.

Device Class

Class B

Approving Authority

Uttar Pradesh

Product Information

The device is intended for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. It is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges. The device is supplied sterile and intended for single use only, Confirm the head direction high frequency knife, manual shaping when necessary, to ensure that the head end towards the face in the middle left. Will guide wire preloaded high-frequency knife, along the road into the endoscopic forceps until its end part appears in the endoscopic view

DJ Fang

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Class B