gudid Primary ID: 1

AMSure Foley Catheter Tray (UDI 1)

Manufactured by AMSINO INTERNATIONAL, INC.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The AMSure Foley Catheter Tray (Model/Catalog Number: 1) is a medical device manufactured by AMSINO INTERNATIONAL, INC.. This product is indexed under FDA Product Code / Category Classification FCM within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 1
Product Code / EMDN: FCM
Device Name: AMSure Foley Catheter TraySilicone Coated Latex Foley Catheter - 5mL Balloon, Inflate with 10mL sterile water.Contents:2000mL Drainage Bag, Silicone Coated Latex Foley Catheter, Wrap, Drape, Fenestrated Drape, Catheter Lubricating Jelly Sachet, Nitrile Golves (2), Forceps, Rayon Balls (5), Povidone-Iodine Solution, 10mL Syringe with Pre-filled Sterile Water, Specimen Container, Lid and Label
Database Sync Date: 2026-08-09 10:01:11

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of AMSure Foley Catheter Tray?

The registered manufacturer of record for AMSure Foley Catheter Tray is AMSINO INTERNATIONAL, INC..

What is the Primary UDI-DI identifier for AMSure Foley Catheter Tray?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1.

What classification code is assigned to this device?

This device is registered under product classification code FCM.

Similar Classification Devices (FCM)

Other Devices by AMSINO INTERNATIONAL, INC.

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