No Certificate Found

Snapshot 2026-10-09 · Link to EUDAMED

ECG Interpretation Software

UDI-DI 04538612914324Basic UDI-DI 4538612010009E

Class IIa · MDR · Fukuda Denshi Co., Ltd.

Scan an inventory CSV

Identification

Model: —
EMDN: Z12050301
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: Yes
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-09 · Link to EUDAMED

Manufacturer

Fukuda Denshi Co., Ltd.

SRN JP-MF-000008253

JP · Tokyo

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

Related UDI-DIs

CardiMax FCP-8100 04538612913488
CardiMax FX-8100 04538612913471
CardiMax FX-8200 04538612913495
CardiMax FX-8300 04538612914287
CardiMax FX-8400 04538612914317
CardiMax FX-9800 04538612916021
ECG AMP Module 04538612100970
ECG AMP Module for LP and 15-lead 04538612100987
ECG Interpretation Software 04538612916007
ECG INTERPRETATION SOFTWARE 04538612913501
ECG INTERPRETATION SOFTWARE 04538612914294
LP Testing Software 04538612916014

Showing 12 of 14 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ecg-interpretation-software-4324 · UDI page: /udi/04538612914324

All devices from Fukuda Denshi Co., Ltd.

Scan an inventory CSV