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AMSure ® Hydrophilic Latex Foley Catheters 1

by Amsino International, Inc. 8 variants

Ref AS42026H

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

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-10704411009078 Basic UDI-DI 10704411009078UDI-DIDate25 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10704411009078 UDI-DI Date7 Jan 2022ListedStatusListed GUDID: not 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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® Hydrophilic Latex Foley Catheter EUDAMED
AMSure ® Hydrophilic Latex Foley Catheters GUDID
Generic Name
Ureteral catheter
Device Name
Hydrophilic Foley Catheter
Model / Reference
AS42026H EUDAMED
1 GUDID
Primary DI / UDI-DI
10704411009078
Basic UDI-DI
B-10704411009078
510(k) Number
FDA Product Code
EZL
EMDN Code
U020201 Ureteral catheters for occlusion
GMDN Term
Ureteral catheter
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.5130
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AS42026H
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K091699)

Show all (12)

Other devices from Amsino International, Inc.

See all devices from Amsino International, Inc. →

Properties

  • Sterile
  • Single Use
  • Contains Latex
  • 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