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AMSure® Urine Meter Drainage Bag 1

by Amsino International, Inc. EUDAMEDGUDID 2 variants

Active European Union

Ref AS327200

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10704411005490 Basic UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10704411005490 UDI-DIDate23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
AMSure® Urine Meter Drainage Bag
Generic Name
Urine flowmeter, single-use
Model / Ref / Catalog
AS327200, 1
Primary DI / UDI-DI
10704411005490
Basic UDI-DI
B-10704411005490
FDA Product Code
FFG
EMDN Code
A06030301 Urine collection bags
GMDN Term
Urine flowmeter, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.1800
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AS327200
GUDID
1
Device ClassEUDAMED
Class I
GUDID
Class II

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Properties

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

Other properties (15)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No