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AMSure® HG Hydrophilic Intermittent Catheter

by Amsino International Inc. 4 variants

Ref HG970610

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10704411021827 Basic UDI-DI 10704411021827UDI-DIDate28 May 2026RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Hydrophilic Intermittent Catheter
Model / Reference
HG970610
Primary DI / UDI-DI
10704411021827
Basic UDI-DI
B-10704411021827
EMDN Code
U01010501 Nelaton catheters, self-lubricating
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000007234
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Amsino International, Inc.

See all devices from Amsino International, Inc. →

Properties

  • Sterile

Other properties (10)

  • 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