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AMSafe® EXTENSION SET 1

by Amsino International, Inc. 9 variants

Ref AE3108

AMSafe® EXTENSION SET 1 (AE3108) is a device classified as Class IIa in the EU and Class II in the US made by Amsino International, Inc., registered in EUDAMED on 12 Jun 2026 (Basic UDI-DI B-10704411003007) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 10704411003007), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10704411003007 Basic UDI-DI 10704411003007UDI-DIDate12 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10704411003007 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10704411003007 registered 12 Jun 2026 Active
  • FDA GUDID UDI-DI 10704411003007 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10704411003007
  2. Registered EUDAMED B-10704411003007

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  • Withdrawn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
AE3108, 1
Primary DI / UDI-DI
10704411003007
Basic UDI-DI
B-10704411003007
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 registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AE3108
GUDID
1
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Intravenous administration tubing extension set

Similar devices in this category

Other devices filed under TUBULAR DEVICES.

Other devices from Amsino International, Inc.

See all devices from Amsino International, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)