Urology and Gynecology Systems - India CDSCO Medical Device Registration

Urology and Gynecology Systems is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000472_851824b7825b6fc61eb8b9bf97baff74_ab27e2f52cbcac9f48206e7f913fce6b. The license holder is Stryker India Pvt. Ltd.,, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Urology and Gynecology Systems

UID: IMP/MD/2023/000472_851824b7825b6fc61eb8b9bf97baff74_ab27e2f52cbcac9f48206e7f913fce6b

License Holder

Stryker India Pvt. Ltd.,

Device Class

Class B

Approving Authority

CDSCO

Product Information

Hysteroscopes and Cystoscopes are intended for use in general urology and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. They are intended for use in, but not limited to, the following types of procedures: ▪ Dilation of the urethra, and cold-slitting of urethral strictures. ▪ Trans-urethral incision and resection of the prostate ▪ Trans-urethral removal of bladder tumors ▪ Trans-cervical resection and ablation of the endometrium ▪ Trans-cervical resection of fibroids