top of page
Experience the URO difference - where quality meets innovation for the well-being of patients and the satisfaction of healthcare professionals.
Strict Hygiene
All products are manufactured within a clean and controlled environment in accordance to ISO 13485 with particular attention provided right down to the last detail to ensure high safety standards are met and that our customers can rely on the products they receive.
Quality Assurance
At Uro Technology, we pay utmost attention to the quality of our products. With our comprehensive Quality Management System, each product is carefully checked and tested at each stages of manufacturing in accordance to ISO 13485 and Directive 93/42/EEC.
Certification
Foley balloon catheters manufactured by Uro Technology are certified internationally by various regulators and standards.
INTERNATIONAL CERTIFICATION
At Uro, our commitment to quality extends to achieving and maintaining international certifications that signify our adherence to the highest standards of excellence. These certifications serve as a testament to our dedication to quality control, safety, and regulatory compliance on a global scale.
ISO 13485 – Medical Devices Quality Management System
At Uro Technology, we pay utmost attention to the quality of our products. With our comprehensive Quality Management System, each product is carefully checked and tested at each stage of manufacturing in accordance to ISO 13485 and Directive 93/42/EEC.
ASTM F623 – Standard Performance Specification for Foley Catheter
This performance specification establishes performance requirements for the short-term utilization of a single-use, balloon-retention catheter, French sizes 12 through 26 inclusive, used by the medical professions for providing a means of bladder drainage by means of the urethra.
Biocompatibility Test
• Genotoxicity Test – ISO 10993 part 3
• Skin Sensitization Test – ISO 10993 part 10
• Skin Irritation Test – ISO 10993 part 10
• Test for Systemic Toxicity – ISO 10993 part 11
• In Vitro Cytotoxicity Test – ISO 10993 part 5
• Test for local effects after implantation –
ISO 10993 part 6
Specific Tests as per ISO 20696:2018
• Flow Rate through Drainage Lumen
• Balloon Integrity; Resistance to Rupture
• Inflated Balloon Response to Traction
• Balloon Volume Maintenance
• Balloon Size and Shaft Size
• Deflation Reliability; Failure to Deflate
Regulatory Registration
• China – NMPA
• European Economic Community – CE Mark
• Japan – MHLW
• Korea – KFDA
• Malaysia – MDA
ISO 20696:2018 – Sterile Urethral Catheters for Single Use
Defines requirements for sterile, single-use urethral catheters with and without balloons.
bottom of page