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AMSure® 100% Silicone Foley Catheter

by Amsino International, Inc. 23 variants

Ref AS40008S

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 6 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 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10704411001898 Basic UDI-DI 10704411001898UDI-DIDate25 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10704411001898 UDI-DI Date23 Sep 2016ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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

Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial
Model / Ref / Catalog
AS40008S, 1
Primary DI / UDI-DI
10704411001898
Basic UDI-DI
B-10704411001898
510(k) Number
FDA Product Code
EZL
EMDN Code
U020201 Ureteral catheters for occlusion
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial
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
AS40008S
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Cleared under the same submission (K082815)

Show all (12)

Other devices from Amsino International, Inc.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: 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