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F9047/4f
EUDAMEDFDA UDIClass I (EU MDR)
Ref F9047/4FModel 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
- F9047/4F model is ECG disposable pregelled electrode with liquid, 28x44mm dimensions, SSC sensor and adapter for 4mm plug connection. The ECG electrode have features that make them absolutely reliable during signal recording. F9047/4F model is used also recording in stress test and for Holter monitoring. FDA UDI
- Model / Reference
- Disposable electrodes for ECG EUDAMEDF9047/4F EUDAMEDFDA UDI
- Description
- F9047/4F model is ECG disposable pregelled electrode with liquid, 28x44mm dimensions, SSC sensor and adapter for 4mm plug connection. The ECG electrode have features that make them absolutely reliable during signal recording. F9047/4F model is used also recording in stress test and for Holter monitoring. FDA UDI
Identifiers
- Catalog Number
- F9047/4F FDA UDI
- Primary DI / UDI-DI
- 08033695725318 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
Category: Electrocardiographic electrode, single-use
F9047/4f by FIAB S.p.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrocardiographic electrode, single-use.
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- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Kendall — Cardinalhealth · Class II
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 4ee8781d-617f-4cbb-946b-32d4e012bd04 61 fields · synced Jul 17, 2026
- FDA UDI f773e3e3-9ac1-4047-8b2f-01680acb0600 36 fields · synced May 30, 2026