Malleable Penile Prosthesis
- UID
- IMP/MD/2021/000117_518a8c0705d6bc07b4e7169508020cca_ccc2a728f88984407b7ed2e108daeac9
- Device class
- Class C
- Brand name
- Rigi 10
- License holder
- Swar Enterprises
- Approving authority
- CDSCO
- Product information
- Rigi10™ Hydrophilic Malleable Penile Prosthesis is intended for implantation into the corpora cavernosa of the penis in men who are diagnosed with erectile dysfunction. The prosthesis is implanted to provide adequate penile rigidity for sexual intercourse.
Malleable Penile Prosthesis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000117_518a8c0705d6bc07b4e7169508020cca_ccc2a728f88984407b7ed2e108daeac9. This device is marketed under the brand name Rigi 10. The license holder is Swar Enterprises, and it is classified as Device Class Class C. The approving authority is CDSCO.
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