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ISE Internal Standard Gen.2 - India CDSCO Medical Device Registration

ISE Internal Standard Gen.2 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000038_fbe1454a1dfaf78ed1f7c342ebb16838_1cacf2169c27d63ce5e06bf21eb3e7a0. This device is marketed under the brand name Calset Vitamin D Total III. The license holder is Roche Diagnostics India 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
ISE Internal Standard Gen.2
UID: IMP/IVD/2018/000038_fbe1454a1dfaf78ed1f7c342ebb16838_1cacf2169c27d63ce5e06bf21eb3e7a0

Brand Name

Calset Vitamin D Total III

Device Class

Class B

Approving Authority

CDSCO

Product Information

The ISE module of the Roche/Hitachi systems is intended for the quantitative determination of sodium, potassium and chloride in serum, plasma or urine using ion selective electrodes

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