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CK- MB testing kit - India CDSCO Medical Device Registration

CK- MB testing kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000049_a47f935263a67f6a0c0c56c96d99d5ce_2a3d7bd0f90b07a97e62e6ae9f20756d. This device is marketed under the brand name PROLISA T4 ELISA. The license holder is Promea Therapeutics Private Limited, and it is classified as Device Class Class B. The approving authority is Telangana.

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 B
CK- MB testing kit
UID: MFG/IVD/2021/000049_a47f935263a67f6a0c0c56c96d99d5ce_2a3d7bd0f90b07a97e62e6ae9f20756d

Brand Name

PROLISA T4 ELISA

Device Class

Class B

Approving Authority

Telangana

Product Information

The intended use of the kit is to solely monitor the level of CK-MB and not diagnose any disorders or diseases

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