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F9028
EUDAMEDFDA UDIClass I (EU MDR)
Ref F9028Model Copper electrodes for ECG
by FIAB S.p.A.
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Electrocardiographic electrode, reusable FDA UDI
- Device Name
- Reusable light electrodes for ECG, active surface 113 mm³ and cable length 28 cm. F9028 model has features that make it absolutely reliable during signal recording with all different ECG on the market. Cable and metallic recording electrode are very light and can be easily positioned using conductive gel. ECG signal is extremely clear thanks to beryllium of which the electrode is made of. FIAB light electrodes can be tapped to all ECGs and monitors with Ø 4 mm snap cable FDA UDI
- Model / Reference
- Copper electrodes for ECG EUDAMEDF9028 EUDAMEDFDA UDI
- Description
- Reusable light electrodes for ECG, active surface 113 mm³ and cable length 28 cm. F9028 model has features that make it absolutely reliable during signal recording with all different ECG on the market. Cable and metallic recording electrode are very light and can be easily positioned using conductive gel. ECG signal is extremely clear thanks to beryllium of which the electrode is made of. FIAB light electrodes can be tapped to all ECGs and monitors with Ø 4 mm snap cable FDA UDI
Identifiers
- Catalog Number
- F9028 FDA UDI
- Primary DI / UDI-DI
- 08033695721983 EUDAMEDFDA UDI
- Basic UDI-DI
- 803300326008000003N5 EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
- GMDN Term
- Electrocardiographic electrode, reusable 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
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
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
F9028 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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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 | 803300326008000003N5 | 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 683676a9-6bbd-4f86-b30d-960661a1ae65 61 fields · synced Sep 18, 2026
- FDA UDI 7ec17500-ca6d-4e96-a6a1-fdcec4efbe1d 36 fields · synced May 30, 2026