Balloon Dilatation Catheter - India CDSCO Medical Device Registration
Balloon Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000346_16eb53f14e746dc332d80db12a830d7a_375ce1726beefba7b96b91cb7b304aad. This device is marketed under the brand name EZDilate-Fixed Wire. The license holder is Olympus Medical Systems India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
EZDilate-Fixed Wire
License Holder
Olympus Medical Systems India Pvt. LtdDevice Class
Approving Authority
CDSCO
Product Information
The EZDilate 3-Stage Balloon Dilatation Catheters are indicated for use in adult and adolescent (EZDilate-Fixed Wire) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
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Brand: EZDilate-Fixed Wire