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AMSure ® Foley Catheters Tray 1

by Amsino International, Inc. EUDAMEDGUDID

Active European Union

Ref AS89816S

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10704411014683 Basic UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10704411014683 UDI-DIDate4 Apr 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

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

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
AMSure® Foley Catheter Tray EUDAMED
AMSure ® Foley Catheters Tray GUDID
Generic Name
Intermittent urethral drainage catheter, non-antimicrobial, single-use
Device Name
Urinary Catheterization/ Collection Kit
Model / Ref / Catalog
AS89816S, 1
Description
400mL Urine Meter attached to 2600mL Drainage Bag 100% Silicone Foley Catheter 5 cc Balloon 16 Fr.
Primary DI / UDI-DI
10704411014683
Basic UDI-DI
B-10704411014683
FDA Product Code
FCM
EMDN Code
U99 Devices for urogenital system - other
GMDN Term
Intermittent urethral drainage catheter, non-antimicrobial, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.5130
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AS89816S
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II
Contains LatexEUDAMED
No
GUDID
Yes

Related devices

Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use

Other devices from Amsino International, Inc.

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Properties

  • Sterile
  • Single Use
  • Contains Latex NoEUDAMEDYesGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No