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Single-Use Needle Guide UA1346

by Bk Medical ApS

Ref UA1346

Single-Use Needle Guide UA1346 is a device classified as Class IIa in the EU and Class II in the US made by Bk Medical ApS, registered in EUDAMED on 24 Jul 2026 (Basic UDI-DI B-05704916001001) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 05704916001001), 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-05704916001001 Basic UDI-DI 05704916001001UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05704916001001 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05704916001001 registered 24 Jul 2026 Active
  • FDA GUDID UDI-DI 05704916001001 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05704916001001
  2. Registered EUDAMED B-05704916001001

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  • Withdrawn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
Single-Use Needle Guide
Generic name
Needle guide, single-use
Device name
UA1346 Single-use needle guide
Model / reference
UA1346
Primary DI / UDI-DI
05704916001001
Basic UDI-DI
B-05704916001001
FDA product code
ITX
EMDN code
A018002 Needle guides
GMDN term
Needle guide, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570
EU registration type
Legacy device (under a directive)
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

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: Needle guide, single-use

Similar devices in this category

Other devices filed under NEEDLE GUIDES.

Other devices from Bk Medical ApS

See all devices from Bk Medical ApS →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)