Tracheal T-Tube - India CDSCO Medical Device Registration
Tracheal T-Tube is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000537_8a9f5ddf9f6232e2962989a287f53114_bfb7f87a2153842987749df455f16a90. The license holder is EON MEDITECH PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is Gujarat.
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License Holder
EON MEDITECH PRIVATE LIMITEDDevice Class
Approving Authority
Gujarat
Product Information
The T-Tube may be used as both a tracheal stent and a tracheotomy tube and may be used under following circumstances: 1. in tracheal stenosis, when the cervical or thoracic airway cannot be repaired, or as a substitute for the cervical trachea when it cannot be reconstituted or reconstructed; 2. as a support following reconstructed cervical trachea ; 3. prior to reconstruction to maintain an adequate airway while waiting for inflammation to subside; 4. as a palliative measure for patients with unresectable carcinoma of the trachea; 5. when there is not enough trachea left to repair because of prior surgery; 6. with segmental resection and anastomosis; 7. when the patient is not a candicate for surgery
