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AMSure® Foley Catheter Tray 1

by Amsino International, Inc. 2 variants

Ref AS89816H, AS89814S, AS89814H, AS89816, AS89314S, AS89818H, AS89318S, AS89314, AS89814, AS89818, AS89316S, AS89316

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10704411014652 Basic UDI-DI Date26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10704411005322 UDI-DI Date1 Jul 2025ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
AMSure® Foley Catheter Tray EUDAMEDGUDID
AMSure ® Foley Catheters Tray GUDID
Generic Name
Indwelling urethral catheterization kit, adult
Intermittent urethral catheterization kit
Intermittent urethral drainage catheter, non-antimicrobial, single-use
Device Name
Urinary Catheterization/ Collection Kit
Model / Ref / Catalog
AS89816H, AS89814S, AS89814H, AS89816, AS89314S, AS89818H, AS89318S, AS89314, AS89814, AS89818, AS89316S, AS89316, 1, AS89414H
Description
400mL. Urine Meter attached to 2600mL drainage bag Hydrophilic Latex Foley Catheter 5 cc Balloon 18 Fr.
400mL. Urine Meter attached to 2600mL drainage bag Hydrophilic Latex Foley Catheter 5 cc Balloon 16 Fr.
400mL. Urine Meter attached to 2600mL drainage bag Hydrophilic Latex Foley Catheter 5 cc Balloon 14 Fr.
400mL Urine Meter attached to 2600mL Drainage Bag 100% Silicone Foley Catheter 5 cc Balloon 14 Fr.
Primary DI / UDI-DI
10704411005322, 10704411005308, 10704411005315, 10704411014669, 10704411003830, 10704411014652, 10704411003823, 10704411014645, 10704411014676, 10704411017066, 10704411017059, 10704411017073, 10704411019602
Basic UDI-DI
B-10704411014652, B-10704411014676, B-10704411014645, B-10704411017066, B-10704411005308, B-10704411014669, B-10704411005322, B-10704411003823, B-10704411017059, B-10704411017073, B-10704411005315, B-10704411003830
FDA Product Code
FCM
EMDN Code
U99 Devices for urogenital system - other
GMDN Term
Indwelling urethral catheterization kit, adult
Intermittent urethral catheterization kit
Intermittent urethral drainage catheter, non-antimicrobial, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.5130
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AS89816H
AS89814S
AS89814H
AS89816
AS89314S
AS89818H
AS89318S
AS89314
AS89814
AS89818
AS89316S
AS89316
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Indwelling urethral catheterization kit, adult

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Properties

  • Sterile
  • Single Use
  • Contains Latex YesEUDAMEDGUDIDNoEUDAMEDGUDID
  • Prescription Use
  • Convenience Kit NoGUDIDYesGUDID
  • Combination Product NoGUDIDYesGUDID
  • Lot / Batch Number
  • Expiration Date

Other properties (14)

  • 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
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No