Pure Global

D Dimer Gen.2 Calibrator Set - India CDSCO Medical Device Registration

D Dimer Gen.2 Calibrator Set is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000038_f9252478239d83c07297024907240f55_f5eb443fdff4b2d38a9ba5c9a55955e6. This device is marketed under the brand name Antithrombin. The license holder is Roche Diagnostics India 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.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class C
D Dimer Gen.2 Calibrator Set
UID: IMP/IVD/2018/000038_f9252478239d83c07297024907240f55_f5eb443fdff4b2d38a9ba5c9a55955e6

Brand Name

Antithrombin

Device Class

Class C

Approving Authority

CDSCO

Product Information

D‑Dimer Gen.2 Calibrator Set is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheets

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing