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Edison EDNCK2001

by Histosonics, Inc

Ref EDNCK2001

Edison EDNCK2001 is a device classified as Class I in the EU and Class II in the US made by Histosonics, Inc, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 0850006962H003MA) and listed in FDA GUDID since 7 Dec 2023 (UDI-DI 00850006962150), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850006962H003MA Basic UDI-DI 00850006962150UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850006962150 UDI-DI Date7 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850006962H003MA registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00850006962150 listed 7 Dec 2023 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00850006962150
  2. Registered EUDAMED 0850006962H003MA

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
HistoSonics Coupling Kit EUDAMED
Edison GUDID
Generic name
Therapeutic oncological/gynaecological ultrasound system
Model / reference
EDNCK2001
Primary DI / UDI-DI
00850006962150 EUDAMED
00850006962051 GUDID
Basic UDI-DI
0850006962H003MA
FDA product code
QGM
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Therapeutic oncological/gynaecological ultrasound system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4405
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00850006962150
GUDID
00850006962051
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00850006962150; FDA GUDID lists 00850006962051), so their flags are not compared. 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: Therapeutic oncological/gynaecological ultrasound system

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)