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Quality Assurance

At Uro Technology, we pay utmost attention to our quality. With our comprehensive Quality Management System, each product is carefully checked and tested at all stages of manufacturing in accordance to ISO 9001 International Quality System, ISO 13485, G.M.P. Norms and CE Mark.
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Strict Hygiene

All products are manufactured under controlled and clean environment in accordance to ISO 13485 with particular care right down to the last detail to ensure high safety standards and great comfort.
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Certification

Foley balloon catheters manufactured by Uro Technology are certified internationally by various regulators and standards.

International Certification

ISO 13485 – Medical Devices Quality Management System

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Regulatory Registration
  • Malaysia – MDA
  • European Economic Community – CE Mark
  • Japan – JGMP
  • China – CFDA
  • Korea – KFDA
  • Gulf States- GHC
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.

BS EN 1616 – Sterile Urethral Catheters for Single Use

Defines requirements for sterile, single-use urethral catheters with and without balloons.

Immerse in Simulated Urine Test for 14 days at 37°C
  • 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
Biocompatibility Test
  • Genotoxicity Test – ISO 10993 part 3
  • Skin Sensitization Test – ISO 10993 part 10
  • Skin Irrigation Test – ISO 10993 part 10
  • Acute Systemic Toxicity Test – ISO 10993 part 11
  • In Vitro Cytotoxicity Test – ISO 10993 part 5

CE Mark Certificate

ISO 9001:2008 Certificate

ISO 13485:2003 Certificate

CHROMA Medical Device Registration Certificate

UROCARE Medical Device Registration Certificate

Registration Certificate of Foreign Medical Device Manufacturer