Foley Catheter – Silicone and Tiemann - India CDSCO Medical Device Registration

Foley Catheter – Silicone and Tiemann is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000325_94c950a26d22d2f87d1957f32eeaa885_d84be1121ef74eeeb83093e4245e5964. This device is marketed under the brand name BIP Foley Catheter latex. The license holder is Neon Laboratories Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Foley Catheter – Silicone and Tiemann

UID: IMP/MD/2019/000325_94c950a26d22d2f87d1957f32eeaa885_d84be1121ef74eeeb83093e4245e5964

Brand Name

BIP Foley Catheter latex

License Holder

Neon Laboratories Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The BIP Foley Catheter - Silicone and BIP Foley Tiemann are intended to be inserted by trained medical staff, for the drainage and/or irrigation of the bladder, and/or for collection/measurement of patient urine. These functions are achieved by inserting the catheter into the vesical cavity of the bladder through the urethra, or by suprapubic catheterisation. BIP Foley Tiemann is only for transurethral use. Bactiguard® coated Foley catheters have been shown to significantly reduce the incidence of bacteriuria, catheter associated urinary tract infections (BIP Foley Catheter latex) and antibiotic use in catheterized patients compared to patients using standard catheters