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Strata - India CDSCO Medical Device Registration

Strata is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000481_c56824838185cbcb5d334a91a4026335_7bb6d3f83da11567cc421d4be2014485. This device is marketed under the brand name Strata NSC Valve. The license holder is India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Strata
UID: IMP/MD/2021/000481_c56824838185cbcb5d334a91a4026335_7bb6d3f83da11567cc421d4be2014485

Brand Name

Strata NSC Valve

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Strata II valve is a shunt component designed to provide continued cerebrospinal fluid (Strata NSC Valve) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The Strata II valve allows the physician to non-invasively adjust the pressure/flow performance level pre- and post-implantation without the need for radiographic confirmation in order to address changing patient needs.

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