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Enteral MSISO-100P

by GBUK Group, Ltd.

Ref MSISO-100P

Enteral MSISO-100P is a Class I device made by GBUK Group, Ltd., registered in EUDAMED on 14 Aug 2026 (Basic UDI-DI B-05060590881835) and listed in FDA GUDID since 28 Oct 2022 (UDI-DI 05060590881835), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05060590881835 Basic UDI-DI 05060590881835UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060590881835 UDI-DI Date28 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05060590881835 registered 14 Aug 2026 Active
  • FDA GUDID UDI-DI 05060590881835 listed 28 Oct 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060590881835
  2. Registered EUDAMED B-05060590881835

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  • Withdrawn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
Enteral
Generic name
Medication transfer straw
Model / Ref / Catalog
MSISO-100P
Primary DI / UDI-DI
05060590881835
Basic UDI-DI
B-05060590881835
FDA product code
KYX
EMDN code
A0280 Syringes - accessories
GMDN term
Medication transfer straw
Device class
Class I
Regulation number
880.6430
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Medication transfer straw

Similar devices in this category

Other devices filed under SYRINGES - ACCESSORIES.

Other devices from GBUK Group, Ltd.

See all devices from GBUK Group, Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (20, all answered No)