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U7752p
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref U7752PModel Disposable electrodes defibrillation, cardioversion, cardiac stimulator, ECG
by FIAB S.p.A.
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- External defibrillation electrode, paediatric, single-use FDA UDI
- Device Name
- Disposable multifunction electrodes for defibrillation, synchronized cardioversion, transcutaneous cardiac stimulation and ECG monitoring, with direct connection to cables and defibrillators, provided with radiotransparent pads and radio-opaque cable. Designed for direct connection to cables and defibrillators, they are characterized by a low impedance and a reduced stimulation threshold, with an excellent adaptability to the patient’s skin. The protective foam insulator and the safety plug eliminate every risk of electric micro-shock. Electrodes equipped with connector for defibrillators PHYSIO-CONTROL. Paediatric version. FDA UDI
- Model / Reference
- Disposable electrodes defibrillation, cardioversion, cardiac stimulator, ECG EUDAMEDU7752P EUDAMEDFDA UDI
- Description
- Disposable multifunction electrodes for defibrillation, synchronized cardioversion, transcutaneous cardiac stimulation and ECG monitoring, with direct connection to cables and defibrillators, provided with radiotransparent pads and radio-opaque cable. Designed for direct connection to cables and defibrillators, they are characterized by a low impedance and a reduced stimulation threshold, with an excellent adaptability to the patient’s skin. The protective foam insulator and the safety plug eliminate every risk of electric micro-shock. Electrodes equipped with connector for defibrillators PHYSIO-CONTROL. Paediatric version. FDA UDI
Identifiers
- Catalog Number
- U7752P FDA UDI
- Primary DI / UDI-DI
- 08054242446449 EUDAMEDFDA UDI
- Basic UDI-DI
- 803300326808000004TX EUDAMED
- 510(k) Number
- K103783 FDA UDI
- FDA Product Code
- LDD FDA UDI
- EMDN Code
- C020401 EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS EUDAMED
- GMDN Term
- External defibrillation electrode, paediatric, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5300 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
U7752p by FIAB S.p.A. — Class IIb — 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 | 803300326808000004TX | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (2)
- EUDAMED acb27a2f-d447-4095-b40f-00ee25b7e771 61 fields · synced Jun 18, 2026
- FDA UDI 323c76d9-721b-4c3f-ab43-4aca09ab576c 37 fields · synced May 30, 2026