Catheters (urinary, central venous, Foley)

Form: Urinary catheters, Central venous catheters, Foley catheters

Strength: Various sizes

Reference Brands: Bard, Teleflex, C.R. Bard, BARDex, ICU Medical, MycoSure

Category: Medical Devices

Catheters (urinary, central venous, Foley) are regulated in the US and EU, supported by dossiers demonstrating safety, efficacy, and production quality compliant with GMP and MDR standards. In the US, FDA approval involves clinical validation and safety data, while in the EU, CE marking certifies conformity with medical device regulations. These products undergo validation, stability testing, and audits, with detailed documentation including safety profiles, performance data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, effective catheter solutions for medical and veterinary practices worldwide, vital for infection control and patient management.