ISO 13485:2016 Certified Manufacturing

Designed for safe, reliable urinary catheterization in veterinary patients, this Foley catheter is produced from medical-grade silicone rubber, offering excellent biocompatibility, low tissue irritation, and reduced risk of urinary tract infection. A uniquely designed tube body with a smooth, atraumatic tip minimizes mucosal damage and reduces resistance during insertion, supporting a smoother catheterization process across a wide range of veterinary patients.

The tube body incorporates a radiopaque line for clear visualization of catheter position under X-ray. A professionally engineered, uniform balloon design helps prevent urine leakage and accidental catheter dislodgement, while fixed wings on each catheter provide a secure anchor point for external stabilization and taping.

Key Features:

• ISO 13485:2016 certified quality management system
• Medical-grade silicone — biocompatible, non-irritating, reduced UTI risk
• Smooth, atraumatic tip design to protect mucosa and ease insertion
• Radiopaque line for X-ray visualization of catheter position
• Uniform balloon design to prevent leakage and catheter displacement
• Fixed wings for secure external stabilization
• Sterile, single-use, latex-free

Available Sizes

All sizes include fixed wings.

Manufactured in an ISO 13485:2016-certified facility. For veterinary use only — not for human use.

MEDAZA EUROPE D.O.O. — LIMITED DEFECT GUARANTEE (VETERINARY DISPOSABLE / ONE-TIME-USE CONSUMABLES)

1. Scope and Nature of Coverage

This guarantee applies exclusively to disposable, single-use veterinary consumables (including but not limited to needles, sutures, catheters, and other single-use disposable items) sold by Medaza Europe D.O.O. Because these products are single-use and intended to be opened and used once, they are not covered by the manufacturer's One (1) Year Limited Depot Warranty, which applies only to reusable hardware devices. Instead, coverage under this guarantee is strictly limited to manufacturing defects or compromised sterile packaging identified prior to use.

2. Warranty Provider and Claim Window

This guarantee is honored by the manufacturer of this particular product, coordinated through Medaza Europe D.O.O. The Buyer must report any manufacturing defect or compromised/breached sterile packaging within three (3) business days of receipt. Claims submitted after this window will not be accepted, as the condition of a disposable product cannot be verified once additional time has passed or the item has entered use.

3. Claim Procedure

• Do Not Use the Product: If a defect or packaging issue is identified, the affected unit(s) must not be opened, used, or discarded pending resolution of the claim.
• Contact Medaza Europe D.O.O.: The Buyer must email contacteurope2@medaza-platform.com within the 3-business-day window with the order number, lot/batch number, and a description of the issue.
• Evidence Required: The Buyer must provide clear photo and/or video documentation of the defect or compromised packaging, including visible lot/batch numbers, as a condition of any claim being reviewed.
• Disposition: Medaza Europe D.O.O. will coordinate with the manufacturer to determine the resolution. Approved claims are resolved by replacement unit(s) or credit, at the manufacturer's discretion. Physical return of used, opened, or potentially contaminated disposable products is not required and will not be accepted for depot inspection, given the single-use and biohazard-sensitive nature of these items; unopened, unused units may be requested for return at the manufacturer's discretion.

4. Universal Recall & Systemic Defect Exception

In the event that a lot or batch is officially determined by the manufacturer, Medaza Europe D.O.O., or an authorized regulatory/competent body governing veterinary devices to be subject to a Universal Recall, Safety Alert, or a verified batch-wide Systemic Manufacturing Defect, the standard 3-business-day claim window and evidence requirements in Sections 2–3 shall be waived for units from the affected lot(s), and the manufacturer will coordinate resolution directly at no cost to the Buyer.

5. Exclusions

This guarantee does not cover:

• Any unit once opened, used, or removed from its original sterile packaging, except where the claim is that the packaging itself was compromised or breached prior to use.
• Damage caused by accident, abuse, liquid exposure, improper storage or handling, improper sterilization or reprocessing of a single-use item, animal bite/chew damage, neglect, or unauthorized modification.
• Normal variability in packaging appearance that does not constitute a breach of the sterile barrier.
• Claims submitted after the 3-business-day window, or without the required lot/batch and photo/video documentation.
• Expired product, or product used or stored outside the manufacturer's labeled conditions.