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AMSure® Urinary Drainage Bag 1

by Amsino International, Inc. 7 variants

Ref AS32600

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-10704411003113 Basic UDI-DI 10704411003113UDI-DIDate25 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10704411003113 UDI-DI Date23 Sep 2016ListedStatusListed 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  • Withdrawn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® Urinary Drainage Bag
Generic Name
Non-wearable adult urine collection bag, open-ended
Device Name
Urine Bag
Model / Ref / Catalog
AS32600, 1
Primary DI / UDI-DI
10704411003113
Basic UDI-DI
B-10704411003113
FDA Product Code
KNX
EMDN Code
A06030301 Urine collection bags
GMDN Term
Non-wearable adult urine collection bag, open-ended
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5250
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AS32600
GUDID
1
Device ClassEUDAMED
Class I
GUDID
Class II

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