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AMSure® Irrigation Tray with Bulb Syringe 1

by Amsino International, Inc.

Ref AS130

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-10704411008101 Basic UDI-DI 10704411008101UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10704411008101 UDI-DI Date30 May 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  • Withdrawn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® Irrigation Tray with Bulb Syringe
Generic Name
Laparoscopic surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
AS130, 1
Primary DI / UDI-DI
10704411008101
Basic UDI-DI
B-10704411008101
FDA Product Code
KYZ
EMDN Code
A020102010202 Infusion and irrigation syringes, luer cone, 3-piece without needle, single-use
GMDN Term
Laparoscopic surgical procedure kit, non-medicated, reusable
Device Class
Class I
Regulation Number
880.6960
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AS130
GUDID
1

Related devices

Category: Laparoscopic surgical procedure kit, non-medicated, reusable

Other devices from Amsino International, Inc.

See all devices from Amsino International, Inc. →

Properties

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

Other properties (16)

  • 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
  • Serial Number: No
  • Manufacturing Date: No