Annuloplasty Device
- UID
- IMP/MD/2022/000101_2f94374abd14ee777b52bfec9c00c5c3_e860cb57be4ad56602b8077c4a4242ae
- Device class
- Class C
- Brand name
- Sovering Annuloplasty Device
- License holder
- Parekh Integrated Services Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- The Carbomedics Annuloflo Device is intended to support the mitral annulus after the surgical repair. The Carbomedics Annuloflex Device is intended to support the mitral or the tricuspid annulus after the surgical repair. The decision on whether or not to undertake annuloplasty can be made only by the surgeon for each individual case based on the assessment of the prospective short and medium-term risks/benefits compared to alternative treatment methods
Annuloplasty Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000101_2f94374abd14ee777b52bfec9c00c5c3_e860cb57be4ad56602b8077c4a4242ae. This device is marketed under the brand name Sovering Annuloplasty Device. The license holder is Parekh Integrated Services Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.
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