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_a19b0c602f10921fa654983a7357cf81. 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_a19b0c602f10921fa654983a7357cf81

Brand Name

Sovering Annuloplasty Device

License Holder

Parekh Integrated Services Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

Memo 3D device is intended to reshape and support the mitral annulus after the surgical repair. The decision to undertake a mitral valve repair must remain with the surgeon after having evaluated short- and long-terms risks and benefits towards alternative procedures and on the visual inspection of the lesion in the individual case.