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Antimicrobial Foley's Balloon Catheter - India CDSCO Medical Device Registration

Antimicrobial Foley's Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000609_1e79ecb2a93588fc984516fe93b746e7_4bc1c2961acb0c043adf1e908cf2f111. This device is marketed under the brand name DIRE, CuSurge. The license holder is Cubit Medisurge LLP., and it is classified as Device Class Class B. The approving authority is Gujarat.

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
Antimicrobial Foley's Balloon Catheter
UID: MFG/MD/2022/000609_1e79ecb2a93588fc984516fe93b746e7_4bc1c2961acb0c043adf1e908cf2f111

Brand Name

DIRE, CuSurge

License Holder

Cubit Medisurge LLP.

Device Class

Class B

Approving Authority

Gujarat

Product Information

Antimicrobial Foley's catheter is intended for the drainage and/or irrigation of the bladder, and/ or for collection/ measurement of patient urine, for simultaneous monitoring of the core body temperature and to significantly reduce the incidence of bacteriuria, catheter associated urinary tract infections (DIRE, CuSurge) and antibiotic use in catheterized patients

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