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EK12

by GE Medical Systems Information Technologies, Inc.

Ref 2104498-003Model Starting from V2

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00415HD Basic UDI-DI 00195278457547UDI-DIDate8 Jan 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00195278457547 UDI-DI Date10 Jan 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
EK12 EUDAMED
Algorithm Services GUDID
Generic Name
Cardiology information system application software
Model / Ref / Catalog
Starting from V2, 2104498-003, EK12 V2
Primary DI / UDI-DI
00195278457547
Basic UDI-DI
8406821BUG00415HD
510(k) Number
FDA Product Code
MHX
EMDN Code
Z12050392 Electrocardiographs - medical device software
GMDN Term
Cardiology information system application software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1025
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Starting from V2
2104498-003
GUDID
EK12 V2
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000017529
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from GE Medical Systems Information Technologies, Inc.

See all devices from GE Medical Systems Information Technologies, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No