Identity
- Trade Name
- ECG INTERPRETATION SOFTWARE EUDAMED
- Device Name
- Electrocardiograph EUDAMED
- Model / Reference
- FP-810 EUDAMEDFP-809 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04538612914294 EUDAMED04538612913501 EUDAMED
- Basic UDI-DI
- 4538612010009E EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ecg Interpretation Software by Fukuda Denshi Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4538612010009E | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fukuda Denshi Co., Ltd.
- EUDAMED SRN
- JP-MF-000008253
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED ef6b3cc7-b836-4a29-bf93-38e433d92d22 61 fields · synced Jul 10, 2026
- EUDAMED 8ecfc46d-3897-4044-88c9-b27de7e243db 61 fields · synced May 18, 2026