Amsure 3-WAY Hydrophilic Latex Foley Catheter

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

AMSure® Hydrophilic Latex Foley Catheter EUDAMED

AMSure ® Hydrophilic Latex Foley Catheters GUDID

Generic Name

Ureteral catheter

Device Name

Hydrophilic Foley Catheter

Model / Reference

AS41022H EUDAMED

1 GUDID

Primary DI / UDI-DI

10704411008989

Basic UDI-DI

B-10704411008989

510(k) Number

K101824 ↗ 510(k)

K091699 ↗ GUDID

FDA Product Code

EZL

EMDN Code

U020201 Ureteral catheters for occlusion

GMDN Term

Ureteral catheter

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 876.5130

EU market of registration

Netherlands

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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See all devices from Amsino International, Inc. →

• What clinical scenarios is this 3-way Foley catheter designed to support, and why is the three-lumen design important?

  This catheter is designed for urinary drainage in patients requiring continuous bladder irrigation, such as those with urinary retention or post-surgical care. The three-lumen design allows for simultaneous drainage of urine, irrigation fluid infusion, and irrigation fluid outflow, ensuring precise fluid management and reducing the risk of clotting or obstruction in the bladder.

• Is this catheter reusable, or is it intended for single-use only? How does this affect its clinical application?

  The AMSURE 3-Way Foley Catheter is explicitly labeled as a single-use, sterile device, meaning it must be discarded after one patient use. This design ensures patient safety by preventing cross-contamination and maintains sterility, which is critical in clinical settings where infection control is paramount.

• What sizes are available for this catheter, and how do I determine the appropriate size for a patient?

  Multiple sizes are available to accommodate varying patient needs, though exact measurements are not specified in the provided data. Typically, Foley catheters are sized by French gauge (Fr), ranging from 8Fr to 30Fr for adult patients. Selection depends on factors like patient anatomy, clinical indication, and physician preference—consult the manufacturer’s sizing guide or clinical protocol for precise recommendations.

• How should this catheter be stored to maintain its sterility and functionality before use?

  Since it is a sterile, single-use device, it must be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until immediately before use to preserve sterility and prevent contamination.

• What regulatory pathways does this device follow, and how does that affect its availability in different markets?

  The catheter is authorized under FDA 510(k) clearance in the U.S. and complies with the MDD (Medical Device Directive) in Europe, classifying it as a Class II device. This means it has undergone regulatory review for safety and performance, ensuring compliance with stringent standards in both markets. Availability may vary by region based on local regulatory requirements.