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Enteral EISO-PFC-12

by GBUK Group, Ltd.

Ref EISO-PFC-12

Enteral EISO-PFC-12 is an ENFit oral/enteral syringe (EU MDD Class IIa; FDA Class II; FDA product code PNR, Enteral Syringes with enteral specific connectors) made by GBUK Group, Ltd., registered in EUDAMED on 14 Aug 2026 (Basic UDI-DI B-05060590883464) and listed in FDA GUDID since 20 Oct 2022 (UDI-DI 05060590883464), 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-05060590883464 Basic UDI-DI 05060590883464UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060590883464 UDI-DI Date20 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05060590883464 registered 14 Aug 2026 Active
  • FDA GUDID UDI-DI 05060590883464 listed 20 Oct 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060590883464
  2. Registered EUDAMED B-05060590883464

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  • Withdrawn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
ENFit oral/enteral syringe, single-use
Model / Ref / Catalog
EISO-PFC-12
Primary DI / UDI-DI
05060590883464
Basic UDI-DI
B-05060590883464
FDA product code
PNR
EMDN code
A020108 Enteral feeding syringes
GMDN term
ENFit oral/enteral syringe, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.5980
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: ENFit oral/enteral syringe, single-use

Similar devices in this category

Other devices filed under ENTERAL FEEDING SYRINGES.

Other devices from GBUK Group, Ltd.

See all devices from GBUK Group, Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Measuring function
  • Lot / batch number
  • Serial number
Other properties (19, all answered No)