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Controls - India CDSCO Medical Device Registration

Controls is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000035_24b6472fcfa59cddd3f7bbc326582b5f_928b3a27314d4be7805a600fa5844daf. This device is marketed under the brand name EDAN. The license holder is INDELOX GLOBAL DISTRIBUTION PRIVATE LIMITED, and it is classified as Device Class Class C. 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 C
Controls
UID: IMP/IVD/2021/000035_24b6472fcfa59cddd3f7bbc326582b5f_928b3a27314d4be7805a600fa5844daf

Brand Name

EDAN

Device Class

Class C

Approving Authority

CDSCO

Product Information

The EDAN i15 Blood Gas and Electrolyte Controls are external multi-analyte quality control material intended to be used for the verification of correct operation and measurement of the EDAN i15 Blood Gas and Electrolyte Analyzer, together with i15 Calibrant Fluid Pack and i15 Test Cartridge for the analysis of pH, blood gases (EDAN), electrolytes (EDAN) and metabolites (EDAN)

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