Identity
- Trade Name
- ECG Filing S/W EUDAMED
- Device Name
- ECG DATA MANAGEMENT SYSTEMS EUDAMED
- Model / Reference
- EFS-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04538612905858 EUDAMED
- Basic UDI-DI
- 453861204000A3 EUDAMED
- EMDN Code
- Z12030282 VITAL SIGNS MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ECG Filing S/W by Fukuda Denshi Co., Ltd. — Class I — 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 | 453861204000A3 | Class I | 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 (1)
- EUDAMED e13de80a-a890-437e-934a-c544398cc21d 61 fields · synced Jun 18, 2026