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F9016ssc
EUDAMEDFDA UDIClass I (EU MDR)
Ref F9016SSCModel Reusable electrodes for ECG
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 diameter Ø 30mm and ball diameter Ø 33mm. F9016SSC 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 EUDAMEDF9016SSC EUDAMEDFDA UDI
- Description
- Reusable praecordial suction chest electrodes for ECG, metallic part diameter Ø 30mm and ball diameter Ø 33mm. F9016SSC 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
- F9016SSC FDA UDI
- Primary DI / UDI-DI
- 08033003263280 EUDAMEDFDA UDI
- Basic UDI-DI
- 803300326008000001MZ 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
F9016ssc 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 | 803300326008000001MZ | 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 4539add9-e51b-4a54-9fe5-b6decccfbac4 61 fields · synced Jul 17, 2026
- FDA UDI d5c4f9d7-bd57-4a62-8a65-aea34c32b40f 36 fields · synced May 30, 2026