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F9029/60
EUDAMEDFDA UDIClass I (EU MDR)
Ref F9029/60Model 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 314 mm³ and cable length 60 cm. F9029/60 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 EUDAMEDF9029/60 EUDAMEDFDA UDI
- Description
- Reusable light electrodes for ECG, active surface 314 mm³ and cable length 60 cm. F9029/60 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
- F9029/60 FDA UDI
- Primary DI / UDI-DI
- 08033695722041 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
F9029/60 by FIAB S.p.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 e89a3308-269d-47cb-a59d-8daac9db2179 61 fields · synced Jul 24, 2026
- FDA UDI f3486f4b-c55e-4539-b30e-aa3b604b27fa 36 fields · synced May 30, 2026