Electrocardiograph - India CDSCO Medical Device Registration

Electrocardiograph is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000508_4a82a66e4497a68b82e31ddb78cf9ba2_9e198e2c2dd0a7e8b299c8bd39b6fa0e. This device is marketed under the brand name MAC 2000. The license holder is Wipro GE Healthcare Private Limited, and it is classified as Device Class Class B. The approving authority is Karnataka.

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CDSCO Registered

Class Class B

Electrocardiograph

UID: MFG/MD/2023/000508_4a82a66e4497a68b82e31ddb78cf9ba2_9e198e2c2dd0a7e8b299c8bd39b6fa0e

Brand Name

MAC 2000

License Holder

Wipro GE Healthcare Private Limited

Device Class

Class B

Approving Authority

Karnataka

Product Information

The MAC 600 Resting ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information for adult and pediatric populations. Basic systems deliver 3 or 12 lead ECGs and can be upgraded to provide software analysis options such as interpretive analysis of the electrocardiogram. Transmission of ECG data to a central ECG cardiovascular information system is optional. The MAC 600 is intended to be used by trained operators in a hospital or medical professional's facility environment as well as used in clinics, physician offices, outreach centers or wherever ECG testing is performed to record ECG signals from surface electrodes.