Skip to content

8L2 Transducer 9032

by Bk Medical ApS

Ref 9032

8L2 Transducer 9032 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 15 Jul 2026 (Basic UDI-DI B-05704916000127) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 05704916000127), 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-05704916000127 Basic UDI-DI 05704916000127UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05704916000127 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05704916000127 registered 15 Jul 2026 Active
  • FDA GUDID UDI-DI 05704916000127 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05704916000127
  2. Registered EUDAMED B-05704916000127

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  • Withdrawn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
8L2 EUDAMED
8L2 Transducer GUDID
Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Device name
8L2 Surface transducer
Model / reference
9032
Description
Peripheral vessel (vascular), Pediatric, Small organs (small parts), Musculoskeletal (conventional and superficial)
Primary DI / UDI-DI
05704916000127
Basic UDI-DI
B-05704916000127
FDA product code
ITX
EMDN code
Z110402010101 Two–dimensional linear–array transcutaneous ultrasound probes
GMDN term
Extracorporeal ultrasound imaging transducer, hand-held
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

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

  • Sterilise before use UDI-DI 05704916000127: EUDAMED states Yes, FDA GUDID states No.

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: Extracorporeal ultrasound imaging transducer, hand-held

Similar devices in this category

Other devices filed under TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES.

Other devices from Bk Medical ApS

See all devices from Bk Medical ApS →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)