Identity
- Trade Name
- Data Management System EUDAMEDFUKUDA DENSHI FDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- ECG DATA MANAGEMENT SYSTEMS EUDAMED
- Model / Reference
- EFS-1000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04538612915932 EUDAMEDFDA UDI
- Basic UDI-DI
- 453861204000A3 EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- Z12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMED
- GMDN Term
- Medical equipment clinical data interfacing software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Data Management System by Fukuda Denshi Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 453861204000A3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 d3ccacbf-66f1-475e-a3ca-729c83a5646a 61 fields · synced Jul 13, 2026
- FDA UDI 9cce9c2a-da39-446a-b4d8-20701b6bd6d2 32 fields · synced May 30, 2026