F9009ssc /ru24-Ssc
EUDAMEDFDA UDIClass I (EU MDR)
by FIAB S.p.A.
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Electrocardiographic electrode, reusable FDA UDI
- Device Name
- Reusable praecordial suction chest electrodes for ECG, metallic part Ø 24mm and ball diameter Ø 33mm. F9009SSC/RU model has features that make itabsolutely reliable during signal recording with all different ECG devices on the market. The metallic part is silver and silver chloride (Ag/AgCl) allowing a safe and clear signal transmission. FIAB suction chest electrodes, thanks to screw and clip connections, can be tapped to all ECG devices and monitors with patient cables which have plug or snap connections. FDA UDI
- Model / Reference
- Reusable electrodes for ECG EUDAMEDF9009SSC /RU24-SSC EUDAMEDF9009SSC/RU FDA UDI
- Description
- Reusable praecordial suction chest electrodes for ECG, metallic part Ø 24mm and ball diameter Ø 33mm. F9009SSC/RU model has features that make itabsolutely reliable during signal recording with all different ECG devices on the market. The metallic part is silver and silver chloride (Ag/AgCl) allowing a safe and clear signal transmission. FIAB suction chest electrodes, thanks to screw and clip connections, can be tapped to all ECG devices and monitors with patient cables which have plug or snap connections. FDA UDI
Identifiers
- Catalog Number
- F9009SSC/RU FDA UDI
- Primary DI / UDI-DI
- 08054242444667 EUDAMEDFDA UDI
- Basic UDI-DI
- 803300326008000002N3 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Electrocardiographic electrode, single-use
F9009ssc /ru24-Ssc 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
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803300326008000002N3 | 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 f7839760-9b89-437b-8b3c-669fb74c842f 61 fields · synced Aug 3, 2026
- FDA UDI 4b2bd10c-360b-418e-8614-0037bdd4b899 36 fields · synced May 30, 2026