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AMSafe® Extension Set 1

by Amsino International, Inc. 9 variants

Ref AE3107

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10704411002994 Basic UDI-DI 10704411002994UDI-DIDate12 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10704411002994 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  • Withdrawn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
AMSafe® Extension Set
Generic Name
Intravenous administration tubing extension set
Device Name
Intravenous Administration Set and Accessories
Model / Ref / Catalog
AE3107, 1
Primary DI / UDI-DI
10704411002994
Basic UDI-DI
B-10704411002994
FDA Product Code
FPA
EMDN Code
A03040199 Infusion kits (with or w/o pump), single-use - other
GMDN Term
Intravenous administration tubing extension set
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5440
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AE3107
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Intravenous administration tubing extension set

Other devices from Amsino International, Inc.

See all devices from Amsino International, Inc. →

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