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AMSure® Urethral Self Catheterization Kit 16Fr.

by Amsino International, Inc.

Ref AS85016K

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 7 Oct 2026. What this means

Regulatory status

as of registry sync 7 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10704411007593 Basic UDI-DI 10704411007593UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10704411007593 UDI-DI Date28 Apr 2018ListedStatusListed 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  • Withdrawn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® Urethral Self Catheterization Kit EUDAMED
AMSure® Urethral Self Catheterization Kit 16Fr. GUDID
Generic Name
Intermittent urethral catheterization kit
Device Name
Urinary Catheterization/ Collection Kit
Model / Ref / Catalog
AS85016K, 1
Primary DI / UDI-DI
10704411007593
Basic UDI-DI
B-10704411007593
FDA Product Code
FCM
EMDN Code
U99 Devices for urogenital system - other
GMDN Term
Intermittent urethral catheterization kit
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
AS85016K
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Combination Product
  • Lot / Batch Number
  • Expiration Date

Other properties (15)

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