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ILR ECG Analyzer

by Implicity

Ref IM007

ILR ECG Analyzer (IM007) is a device classified as Class I in the EU and Class II in the US made by Implicity, registered in EUDAMED on 22 Feb 2022 (Basic UDI-DI B-03770025266008), cleared under FDA 510(k) K210543 on 3 Nov 2021 and listed in FDA GUDID since 15 Apr 2024 (UDI-DI 03770025266008), active as of 22 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210543

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03770025266008 UDI-DI Date15 Apr 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-03770025266008 Basic UDI-DI 03770025266008UDI-DIDate22 Feb 2022RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK210543 Date3 Nov 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03770025266008 registered 22 Feb 2022 Active
  • FDA 510(k) K210543 decided 3 Nov 2021 Active
  • FDA GUDID UDI-DI 03770025266008 listed 15 Apr 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K210543
  2. Registered EUDAMED B-03770025266008
  3. Listed FDA GUDID 03770025266008

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Cardiology information system application software
Model / Ref / Catalog
IM007, V1.1.4
Primary DI / UDI-DI
03770025266008
Basic UDI-DI
B-03770025266008
510(k) Number
FDA product code
DQK
EMDN code
Z12040182 General medicine diagnosis and monitoring instruments - software accessories
GMDN term
Cardiology information system application software
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1425
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
IM007
GUDID
V1.1.4
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.

Manufacturer details

EUDAMED SRN
FR-MF-000014184

Similar devices in this category

Other devices filed under GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES.

Other devices from Implicity

Properties

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