Annuloplasty Device - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

Annuloplasty Device

UID: IMP/MD/2022/000101_2f94374abd14ee777b52bfec9c00c5c3_e860cb57be4ad56602b8077c4a4242ae

Brand Name

Sovering Annuloplasty Device

License Holder

Parekh Integrated Services Pvt. Ltd.

Device Class

Class C

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