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F9047/4fl
EUDAMEDFDA UDIClass I (EU MDR)
Ref F9047/4FLModel Disposable electrodes for ECG
by FIAB S.p.A.
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- F9047/4FL model is ECG disposable pregelled electrode with liquid gel, 28x44mm dimension and equipped with 4mm plug connection. The ECG electrode have features that make them absolutely reliable during signal recording. F9047/4FL model is used also recording in stress test and for Holter monitoring. They are compatible with different ECG devices on the market. After opening, the pouch can be folded to ensure a better preservation of the electrodes that remain inside. The products are Latex-free. FDA UDI
- Model / Reference
- Disposable electrodes for ECG EUDAMEDF9047/4FL EUDAMEDFDA UDI
- Description
- F9047/4FL model is ECG disposable pregelled electrode with liquid gel, 28x44mm dimension and equipped with 4mm plug connection. The ECG electrode have features that make them absolutely reliable during signal recording. F9047/4FL model is used also recording in stress test and for Holter monitoring. They are compatible with different ECG devices on the market. After opening, the pouch can be folded to ensure a better preservation of the electrodes that remain inside. The products are Latex-free. FDA UDI
Identifiers
- Catalog Number
- F9047/4FL FDA UDI
- Primary DI / UDI-DI
- 08054242440096 EUDAMEDFDA UDI
- Basic UDI-DI
- 803300326608000001SB EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
- GMDN Term
- Electrocardiographic electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
F9047/4fl by FIAB S.p.A. — 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 | 803300326608000001SB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (2)
- EUDAMED 5d957dc1-1d8c-42d4-a6ae-e166414b8427 61 fields · synced Jun 18, 2026
- FDA UDI 3633bd16-6e21-449d-b136-e2bd6dddb420 36 fields · synced May 30, 2026