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AMSure ® HG Hydrophilic Intermittent Urethral Catheter 1

by Amsino International, Inc. 4 variants

Ref HG971616

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-10704411008859 Basic UDI-DI 10704411008859UDI-DIDate25 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10704411008859 UDI-DI Date2 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  • Withdrawn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® HG Hydrophilic Intermittent Urethral Catheter EUDAMED
AMSure ® HG Hydrophilic Intermittent Urethral Catheter GUDID
Generic Name
Intermittent urethral drainage catheter, non-antimicrobial, single-use
Device Name
Hydrophilic Intermittent Catheter
Model / Ref / Catalog
HG971616, 1
Primary DI / UDI-DI
10704411008859
Basic UDI-DI
B-10704411008859
FDA Product Code
EZD
EMDN Code
U01010501 Nelaton catheters, self-lubricating
GMDN Term
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
HG971616
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Amsino International, Inc.

See all devices from Amsino International, Inc. →

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