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Disposable Needle Guide UA1344

by Bk Medical ApS

Ref UA1344

Disposable Needle Guide UA1344 is a device classified as Class I 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-05704916000967), cleared under FDA 510(k) K223830 on 11 Apr 2023 (3 earlier submissions) and listed in FDA GUDID since 30 Apr 2025 (UDI-DI 05704916000967), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

6 ongoing

Recall on shared 510(k) K223830; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223830

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05704916000967 Basic UDI-DI 05704916000967UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05704916000967 UDI-DI Date30 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223830 Date11 Apr 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05704916000967 registered 24 Jul 2026 Active
  • FDA 510(k) K223830 decided 11 Apr 2023 Active· +3 more in the status table
  • FDA GUDID UDI-DI 05704916000967 listed 30 Apr 2025 Listed

Recalls

6 recalls · 6 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-0437-2026 FDA Class II initiated 9 Oct 2025 on shared 510(k) K223830
    • Ongoing Z-0440-2026 FDA Class II initiated 9 Oct 2025 on shared 510(k) K223830
    • Ongoing Z-0438-2026 FDA Class II initiated 9 Oct 2025 on shared 510(k) K223830
    • Ongoing Z-0439-2026 FDA Class II initiated 9 Oct 2025 on shared 510(k) K223830

    GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

    • Ongoing Z-0136-2025 FDA Class II initiated 4 Sep 2024 on shared 510(k) K223830

    The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.

    • Ongoing Z-0813-2024 FDA Class II initiated 30 Nov 2023 on shared 510(k) K223830

    An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

12 dated events

  1. Cleared FDA 510(k) K180737
  2. Cleared FDA 510(k) K223830
  3. Recall initiated FDA recalls Z-0813-2024
  4. Recall initiated FDA recalls Z-0136-2025
  5. Listed FDA GUDID 05704916000967
  6. Recall initiated FDA recalls Z-0437-2026
  7. Recall initiated FDA recalls Z-0440-2026
  8. Recall initiated FDA recalls Z-0438-2026
  9. Recall initiated FDA recalls Z-0439-2026
  10. Registered EUDAMED B-05704916000967

2 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Disposable Needle Guide
Generic name
Needle guide, single-use
Device name
UA1344 Single-use needle guide
Model / reference
UA1344
Primary DI / UDI-DI
05704916000967
Basic UDI-DI
B-05704916000967
510(k) Number
FDA product code
ITX
EMDN code
A018002 Needle guides
GMDN term
Needle guide, single-use
Device class
Class I 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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 05704916000967: EUDAMED states Yes, FDA GUDID states No.

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: Needle guide, single-use

Cleared under the same submission (K173569)

and 1 more cleared under K173569

Cleared under the same submission (K180737)

and 1 more cleared under K180737

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