Video Duodenoscope - India CDSCO Medical Device Registration
Video Duodenoscope is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001200_7a1e3a65d1f2905e80c7654741ff8f37_5d28a2984752b08c810f8fc4529b5f02. The license holder is Pentax Medical India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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License Holder
Pentax Medical India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The PENTAX Duodenoscope is intended to provide optical visualization of ##PLACEHOLDER_0##, and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts. This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
