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Insertion Pack - India CDSCO Medical Device Registration

Insertion Pack is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000741_7a77592dbb87aa124e60f06cd9ecab45_df236cc2500cec50bd062ddc1286c287. This device is marketed under the brand name Sonablate. The license holder is NovoMed Incorporation Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class B
Insertion Pack
UID: IMP/MD/2023/000741_7a77592dbb87aa124e60f06cd9ecab45_df236cc2500cec50bd062ddc1286c287

Brand Name

Sonablate

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Sonablate Insertion Pack is intended to be used with the Sonablate System. The Sonablate Probe Tip Kit contains components to cover the tip of the Sonablate Probe, to create a contained bolus of water that acts as the transrectal interface to the patient. The intended use of the Water Path Kit is to provide a means of coupling ultrasonic energy from a transducer into a patientโ€™s tissue for imaging and ablating said tissue, by circulating water as a couplant that is degassed and is temperature controlled.

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