Skip to content

Sonata Dispersive Electrode

by Gynesonics, Inc.

Ref DE-002, DE-001

Sonata Dispersive Electrode (DE-002) is a device classified as Class IIb in the EU and Class II in the US made by Gynesonics, Inc., registered in EUDAMED on 30 Apr 2026 (Basic UDI-DI 081792902RFDEEB), cleared under FDA 510(k) K250705 on 2 Apr 2025 and listed in FDA GUDID since 7 Jul 2021 (UDI-DI 30817929020474), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250705

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081792902RFDEEB Basic UDI-DI Date30 Apr 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK250705 Date2 Apr 2025DecidedStatusActive
United StatesGUDID listing GUDID Number30817929020474 UDI-DI Date7 Jul 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081792902RFDEEB registered 30 Apr 2026 Active
  • FDA 510(k) K250705 decided 2 Apr 2025 Active
  • FDA GUDID UDI-DI 30817929020474 listed 7 Jul 2021 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 30817929020474
  2. Cleared FDA 510(k) K250705
  3. Registered EUDAMED 081792902RFDEEB

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Electrosurgical return electrode, single-use
Model / Ref / Catalog
DE-002, DE-001
Primary DI / UDI-DI
30817929020474, 10817929020364
Basic UDI-DI
081792902RFDEEB
Direct marketing DI
10817929020364
510(k) Number
FDA product code
KNF
EMDN code
Z12080299 Gynaecology and fertility treatment instruments - other
GMDN term
Electrosurgical return electrode, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
884.4160
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000017044
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER.

Other devices from Gynesonics, Inc.

See all devices from Gynesonics, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date YesGUDIDNoGUDID
  • Manufacturing date NoGUDIDYesGUDID
Other properties (20, all answered No)