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sigma complete + hep - India CDSCO Medical Device Registration

sigma complete + hep is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000088_7dc76750401a99461ba8032b4c75f11a_47b39c47daad8fb2debf7504fbb7509b. This device is marketed under the brand name ROTEM®. The license holder is Instrumentation Laboratory 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.

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CDSCO Registered
Class Class C
sigma complete + hep
UID: IMP/IVD/2021/000088_7dc76750401a99461ba8032b4c75f11a_47b39c47daad8fb2debf7504fbb7509b

Brand Name

ROTEM®

Device Class

Class C

Approving Authority

CDSCO

Product Information

ROTEM sigma complete + hep is a ROTEM system cartridge containing reagents for the assessment of coagulation and its interaction with thrombocytes in citrated whole blood

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