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Humanscan 3PAX-B04

by Humanscan Company, Ltd.

Ref KTZ280293Model 3Sp-D

Humanscan 3PAX-B04 (500395) is an extracorporeal ultrasound imaging transducer (EU MDD Class IIa; FDA Class II; FDA product code ITX, Transducer, Ultrasonic, Diagnostic) made by Humanscan Company, Ltd., registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI B-08809476810098) and listed in FDA GUDID since 18 May 2021 (UDI-DI 08809476810098), 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-08809476810098 Basic UDI-DI 08809476810098UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809476810098 UDI-DI Date18 May 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08809476810098 registered 23 Jun 2026 Active
  • FDA GUDID UDI-DI 08809476810098 listed 18 May 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809476810098
  2. Registered EUDAMED B-08809476810098

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  • Withdrawn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
3Sp-D EUDAMED
Humanscan GUDID
Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Device name
Medical Ultrasound Transducer
Model / Ref / Catalog
3Sp-D EUDAMED
KTZ280293 EUDAMED
3PAX-B04 GUDID
500395 GUDID
Primary DI / UDI-DI
08809476810098
Basic UDI-DI
B-08809476810098
FDA product code
ITX
EMDN code
Z110402010301 Transcutaneous ultrasound sector probes (phased array), two–dimensional
GMDN term
Extracorporeal ultrasound imaging transducer, hand-held
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Norway
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
3Sp-D
KTZ280293
GUDID
3PAX-B04
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: Extracorporeal ultrasound imaging transducer, hand-held

Similar devices in this category

Other devices filed under TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL.

Other devices from Humanscan Company, Ltd.

See all devices from Humanscan Company, Ltd. →

Properties

  • Serial number
  • Manufacturing date
Other properties (21, all answered No)