Software(EMBLEM S-ICD Automated Screening Tool ) - India CDSCO Medical Device Registration
Software(EMBLEM S-ICD Automated Screening Tool ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001193_fc627bc700f6bf448d03bdb5c79e1abe_f50872989e77f919876b8aa9193699a9. This device is marketed under the brand name AST. The license holder is M/s Boston Scientific India Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
AST
License Holder
M/s Boston Scientific India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The AST application is solely intended to screen patients for S-ICD implant and is not intended to be used for any cardiac diagnostic purpose.
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