Identity
- Trade Name
- ECG Interpretation Software EUDAMEDFUKUDA DENSHI FDA UDI
- Generic Name
- Software upgrade/unlocking key FDA UDI
- Device Name
- Electrocardiograph EUDAMED
- Model / Reference
- FP-908A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04538612916007 EUDAMEDFDA UDI
- Basic UDI-DI
- 4538612010009E EUDAMED
- 510(k) Number
- K173226 FDA UDI
- FDA Product Code
- DPS FDA UDI
- EMDN Code
- Z12050382 ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Software upgrade/unlocking key FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2340 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ECG Interpretation Software by Fukuda Denshi Co., Ltd. — Class IIa — 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 | 4538612010009E | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 6273adfc-4565-4e34-b026-89b8ba5f3bcc 61 fields · synced Jul 10, 2026
- FDA UDI 94060d4e-9075-4f9d-af7f-08f92d2a6326 33 fields · synced May 30, 2026