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Hematology analyzer - India CDSCO Medical Device Registration

Hematology analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000304_7df8fb1e620622aea6c9f011daf86afe_f032e0898d1e1469a1a0b82b99594db6. This device is marketed under the brand name Pentra. The license holder is HORIBA India Pvt. Ltd., and it is classified as Device Class Class A. 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 A
Hematology analyzer
UID: IMP/IVD/2023/000304_7df8fb1e620622aea6c9f011daf86afe_f032e0898d1e1469a1a0b82b99594db6

Brand Name

Pentra

Device Class

Class A

Approving Authority

CDSCO

Product Information

The ABX Micros 60 is a fully automated (Pentra) hematology analyzer used for invitrodiagnostics testing of Whole Blood specimens and Whole Blood component concentrates.The device is available in 16 and 18 parameters and the rate of determination is approximately 60 samples per hour in the optimum configuration

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