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/2023/000684_9919c5f095cb0e1636d4aec10762646b_04fb4016f6c5796f3283177c737731b9. This device is marketed under the brand name DIRE / SUC-safe. The license holder is P H MEDISURGE, and it is classified as Device Class Class B. The approving authority is Gujarat.

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CDSCO Registered

Class Class B

ANTIMICROBIAL FOLEY’S BALLOON CATHETER

UID: MFG/MD/2023/000684_9919c5f095cb0e1636d4aec10762646b_04fb4016f6c5796f3283177c737731b9

Brand Name

DIRE / SUC-safe

License Holder

P H MEDISURGE

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 / SUC-safe) and antibiotic use in catheterized patients