SR12 - India CDSCO Medical Device Registration
SR12 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000976_79cc56c488c12445fac42687e1502f85_a30d3b4aa2309b786c6513750fd4adff. The license holder is Janani, and it is classified as Device Class Class B. The approving authority is CDSCO.
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License Holder
JananiDevice Class
Approving Authority
CDSCO
Product Information
12mm Outer diameter. These are intended to use for uterine aspiration/uterine evacuation in obstetrics and gynecologic patients. Clinical indications for uterine aspiration are treatment of incomplete abortion for uterine sizes up to12 weeks from last menstrual period and endometrial biopsy. Applications for endometrial biopsy may include abnormal uterine bleeding, amenorrhea, and screening for endometrial cancer or endometrial infections. The devices are all supplied in a sterile condition for single or multiple use to many countries in the world.
