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AMSure ® Cystoscopy/Bladder Irrigation Set 1

by Amsino International, Inc.

Ref ABL400

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

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-10704411016106 Basic UDI-DI 10704411016106UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10704411016106 UDI-DI Date13 Apr 2023ListedStatusListed 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.

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  • Withdrawn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® Cystoscopy/Bladder Irrigation Set EUDAMED
AMSure ® Cystoscopy/Bladder Irrigation Set GUDID
Generic Name
Urological irrigation set
Device Name
Bladder Irrigation Set
Model / Ref / Catalog
ABL400, 1
Primary DI / UDI-DI
10704411016106
Basic UDI-DI
B-10704411016106
FDA Product Code
LJH
EMDN Code
A03040201 Bladder irrigation kits, single-use
GMDN Term
Urological irrigation set
Device Class
Class I 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
ABL400
GUDID
1
Device ClassEUDAMED
Class I
GUDID
Class II

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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