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Rf-Dgp-Is

by St. Jude Medical, Inc.

Ref RF-DGP-IS

Rf-Dgp-Is is a device classified as Class IIb in the EU and Class II in the US made by St. Jude Medical, Inc., registered in EUDAMED on 5 Jun 2026 (Basic UDI-DI 5415067RFA0002EN), cleared under FDA 510(k) K203293 on 21 Jan 2022 and listed in FDA GUDID since 25 Oct 2023 (UDI-DI 05415067034519), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K203293

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415067RFA0002EN Basic UDI-DI 05415067034519UDI-DIDate5 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067034519 UDI-DI Date25 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK203293 Date21 Jan 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5415067RFA0002EN registered 5 Jun 2026 Active
  • FDA 510(k) K203293 decided 21 Jan 2022 Active
  • FDA GUDID UDI-DI 05415067034519 listed 25 Oct 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K203293
  2. Listed FDA GUDID 05415067034519
  3. Registered EUDAMED 5415067RFA0002EN

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  • Withdrawn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
RF-DGP-IS
Primary DI / UDI-DI
05415067034519
Basic UDI-DI
5415067RFA0002EN
510(k) Number
FDA product code
GXD
EMDN code
K020380 Devices for surgery with radiofrequency generator, single-use - accessories
GMDN term
Electrosurgical return electrode, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.4400
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.

Related devices

Category: Electrosurgical return electrode, single-use

Cleared under the same submission (K203293)

Similar devices in this category

Other devices filed under DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Single use
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)