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Afr-00015

by Medtronic, Inc.

Ref AFR-00015

Afr-00015 is a device classified as Class I in the EU and Class II in the US made by Medtronic, Inc., registered in EUDAMED on 13 May 2026 (Basic UDI-DI 0763000B00031998M), cleared under FDA 510(k) K241828 on 1 Nov 2024 and listed in FDA GUDID since 15 Aug 2025 (UDI-DI 00763000980108), 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, self-declared

Class I: no certifier involved

510(k) K241828

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 Number0763000B00031998M Basic UDI-DI 00763000980108UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000980108 UDI-DI Date15 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241828 Date1 Nov 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00031998M registered 13 May 2026 Active
  • FDA 510(k) K241828 decided 1 Nov 2024 Active
  • FDA GUDID UDI-DI 00763000980108 listed 15 Aug 2025 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K241828
  2. Listed FDA GUDID 00763000980108
  3. Registered EUDAMED 0763000B00031998M

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  • Withdrawn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
Cardiac mapping system reference patch
Device name
Impedance Localization Patch Kit
Model / reference
AFR-00015
Primary DI / UDI-DI
00763000980108, 00763000980092
Basic UDI-DI
0763000B00031998M
510(k) Number
FDA product code
DQK
EMDN code
C020180 Cardiac electrophysiology and mapping devices - accessories
GMDN term
Cardiac mapping system reference patch
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1425
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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.

Similar devices in this category

Other devices filed under CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

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