gudid Primary ID: 1

AMSure Foley Catheters 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 Catheters 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: 400mL. Urine Meter attached to 2600mL drainage bag Hydrophilic Latex Foley Catheter5 cc Balloon14 Fr.
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 Catheters Tray?

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

What is the Primary UDI-DI identifier for AMSure Foley Catheters 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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