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CDSCO UID IMP/IVD/2021/000035_24b6472fcfa59cddd3f7bbc326582b5f_928b3a27314d4be7805a600fa5844daf

Controls

INDELOX GLOBAL DISTRIBUTION PRIVATE LIMITED·Device Class Class C·India CDSCO·Brand: EDAN
Registration details
UID
IMP/IVD/2021/000035_24b6472fcfa59cddd3f7bbc326582b5f_928b3a27314d4be7805a600fa5844daf
Device class
Class C
Brand name
EDAN
License holder
INDELOX GLOBAL DISTRIBUTION PRIVATE LIMITED
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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About this record

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.

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