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Snapshot 2026-10-09 · Link to EUDAMED

ECG INTERPRETATION SOFTWARE

UDI-DI 04538612913501Basic UDI-DI 4538612010009E

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

Identification
Model
—
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)

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Canonical device page: /device/ecg-interpretation-software-3501 · UDI page: /udi/04538612913501

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