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/2023/000830_4a82a66e4497a68b82e31ddb78cf9ba2_2806db54688a9128b53b07fde94a3a42. This device is marketed under the brand name MAC 5. The license holder is Wipro GE Medical Device Manufacturing 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/2023/000830_4a82a66e4497a68b82e31ddb78cf9ba2_2806db54688a9128b53b07fde94a3a42

Brand Name

MAC 5

License Holder

Wipro GE Medical Device Manufacturing Private Limited

Device Class

Class B

Approving Authority

Karnataka

Product Information

The MAC 5 Resting ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult or pediatric populations. Basic system delivers 3, 6, or 12 lead ECG’s and interpretive analysis. Transmission and reception of ECG data and other clinical data to and from a central clinical information system is optional. The MAC 5 Resting ECG Analysis System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital, medical professional’s facility or wherever ECG testing is performed.