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Humanscan 5721640

by Humanscan Company, Ltd.

Ref 5721640Model L3-9i-RS

Humanscan 5721640 (500395) is a device classified as Class IIa in the EU and Class II in the US made by Humanscan Company, Ltd., registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI B-08809476810081) and listed in FDA GUDID since 18 May 2021 (UDI-DI 08809476810081), 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-08809476810081 Basic UDI-DI 08809476810081UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809476810081 UDI-DI Date18 May 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08809476810081 registered 23 Jun 2026 Active
  • FDA GUDID UDI-DI 08809476810081 listed 18 May 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809476810081
  2. Registered EUDAMED B-08809476810081

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  • Withdrawn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
L3-9i-RS EUDAMED
Humanscan GUDID
Generic name
Surgical ultrasound imaging transducer
Device name
Medical Ultrasound Transducer
Model / Ref / Catalog
5721640, L3-9i-RS, 500395
Primary DI / UDI-DI
08809476810081
Basic UDI-DI
B-08809476810081
FDA product code
ITX
EMDN code
Z110402010101 Two–dimensional linear–array transcutaneous ultrasound probes
GMDN term
Surgical ultrasound imaging transducer
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 · 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: Surgical ultrasound imaging transducer

Similar devices in this category

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

Other devices from Humanscan Company, Ltd.

See all devices from Humanscan Company, Ltd. →

Properties

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