Digital Colposcope - India CDSCO Medical Device Registration
Digital Colposcope is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000474_19d18b17045cb6a8dc448c4d29036552_6c037f11f688670ab0899663466a13f7. This device is marketed under the brand name DYSIS Digital Colposcope. The license holder is Morulaa Health Tech Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
DYSIS Digital Colposcope
License Holder
Morulaa Health Tech Pvt LtdDevice Class
Approving Authority
CDSCO
Product Information
DYSIS is a digital colposcope intended to provide magnified viewing of the vagina, cervix and external genitalia. DYSIS is used to diagnose abnormalities and select areas for biopsy. DYSIS acquires, displays and documents high resolution still and sequentially captured images and videos and provides colour coded mapping of the aceto-whitening effect to facilitate and assist assessment and documentation. Reviewing the DYSISmap should never replace the thorough evaluation of the cervix by clinicians.
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