Umbrella Keel - India CDSCO Medical Device Registration
Umbrella Keel is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000481_a5ad5da6ee605eb1d01192046f15b77c_8b009f2da7a1694422027e3da7c2455c. The license holder is EON MEDITECH PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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License Holder
EON MEDITECH PRIVATE LIMITEDDevice Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
Umbrella Keels are designed for use following repair of anterior glottic stenosis, subsequent to removal of a laryngeal stent, to insure reformation of a sharp anterior commissure and to prevent formation of an anterior web. Clear umbrella keels are also available. Both are indicated for use after hemilaryngectomy to prevent stenosis. The soft, conforming structure consists of an umbrella-like extralaryngeal cover and a thin intralaryngeal insert. The extralaryngeal surface is secured to the thyroid laminae to protect the thyrotomy repair. It is designed so that, with a Last figure suture, the keel can be held tightly enough to inhibit synchronous motion between the intralaryngeal keel insert and the vocal cords, thus preventing granulation formation and preserving phonation
