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_842a89f035d7e409ac698a40aa5071b5. 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_842a89f035d7e409ac698a40aa5071b5

Brand Name

MAC 2000

License Holder

Wipro GE Healthcare Private Limited

Device Class

Class B

Approving Authority

Karnataka

Product Information

The MAC 2000 ECG Analysis System is a portable device intended to be used by or under the direct supervision of a licensed healthcare practitioner using surface electrodes to acquire, analyze, display, and record information for adult and pediatric populations in a hospital, medical professional’s facility, clinics, physician’s office or outreach centers