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Dash 6 15281100

by GBUK Group, Ltd.

Ref 15281100

Dash 6 15281100 is a device classified as Class I in the EU and Class II in the US made by GBUK Group, Ltd., registered in EUDAMED on 14 Aug 2026 (Basic UDI-DI B-05060498301626) and listed in FDA GUDID since 2 Jun 2023 (UDI-DI 05060498301626), 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-05060498301626 Basic UDI-DI 05060498301626UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060498301626 UDI-DI Date2 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05060498301626 registered 14 Aug 2026 Active
  • FDA GUDID UDI-DI 05060498301626 listed 2 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060498301626
  2. Registered EUDAMED B-05060498301626

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  • Withdrawn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
Dash 6
Generic name
Medication transfer needle, filtering
Model / Ref / Catalog
15281100
Primary DI / UDI-DI
05060498301626
Basic UDI-DI
B-05060498301626
FDA product code
BSP
EMDN code
A0280 Syringes - accessories
GMDN term
Medication transfer needle, filtering
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.5150
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Medication transfer needle, filtering

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
  • Lot / batch number
Other properties (22, all answered No)