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Dash 6 15490050

by GBUK Group, Ltd.

Part of a family of 7 devices: see the family page

Ref 15490050Model 15110001

Dash 6 15490050 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 13 May 2026 (Basic UDI-DI 50560383NeuraxialAcc2T) and listed in FDA GUDID since 2 Jun 2023 (UDI-DI 05060498302302), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number50560383NeuraxialAcc2T Basic UDI-DI 05060498302302UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060498302302 UDI-DI Date2 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 50560383NeuraxialAcc2T registered 13 May 2026 Active
  • FDA GUDID UDI-DI 05060498302302 listed 2 Jun 2023 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 05060498302302
  2. Registered EUDAMED 50560383NeuraxialAcc2T

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Dash 6
Generic name
Medication transfer needle, filtering
Model / Ref / Catalog
15490050, 15110001
Primary DI / UDI-DI
05060498302302 EUDAMED
05060498306898 GUDID
Basic UDI-DI
50560383NeuraxialAcc2T
Unit of use DI
05060498307710
FDA product code
BSP
EMDN code
A019001 Blunt needles
GMDN term
Medication transfer needle, filtering
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.5150
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05060498302302
GUDID
05060498306898
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 05060498302302; FDA GUDID lists 05060498306898), so their flags are not compared. 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 NEEDLES FOR OTHER PROCEDURES.

Other devices from GBUK Group, Ltd.

See all devices from GBUK Group, Ltd. →

Properties

  • Single use
  • Administering medicine
  • Lot / batch number
Other properties (22, all answered No)