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D-Dimer Test - India CDSCO Medical Device Registration

D-Dimer Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000413_783d382717de19fab419470871e3ab28_fc2f26a1ce5a73128092288f528b1f0b. This device is marketed under the brand name Finecare cTn I/CK-MB/Myo Rapid Quantitative Test. The license holder is Star Biomed Pvt. Ltd., 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
D-Dimer Test
UID: IMP/IVD/2021/000413_783d382717de19fab419470871e3ab28_fc2f26a1ce5a73128092288f528b1f0b

Brand Name

Finecare cTn I/CK-MB/Myo Rapid Quantitative Test

License Holder

Star Biomed Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Finecareโ„ข cTn I/CK-MB/Myo Rapid Quantitative Test is a fluorescence immunoassay used along with Finecareโ„ข FIA System (Finecare cTn I/CK-MB/Myo Rapid Quantitative Test) for quantitative determination of cardiac Troponin I (Finecare cTn I/CK-MB/Myo Rapid Quantitative Test), Creatine Kinase-MB and Myoglobin in human whole blood, serum or plasma

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