F9089p/100
EUDAMEDFDA UDIClass I (EU MDR)
by FIAB S.p.A.
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- Disposable ECG pediatric electrodes with solid gel, 36x32mm dimension, Silver/Silver Chloride(SSC) sensor and stainless steel snap. F9089P/100 model are suitable both for rest and stress or Holter ECG recording, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording and permits the signal recovery after defibrillator discharge . The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids. FDA UDI
- Model / Reference
- Disposable electrodes for ECG EUDAMEDF9089P/100 EUDAMEDFDA UDI
- Description
- Disposable ECG pediatric electrodes with solid gel, 36x32mm dimension, Silver/Silver Chloride(SSC) sensor and stainless steel snap. F9089P/100 model are suitable both for rest and stress or Holter ECG recording, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording and permits the signal recovery after defibrillator discharge . The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids. FDA UDI
Identifiers
- Catalog Number
- F9089P/100 FDA UDI
- Primary DI / UDI-DI
- 08054242449655 EUDAMEDFDA UDI
- Basic UDI-DI
- 803300326608000001SB EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
- GMDN Term
- Electrocardiographic electrode, single-use 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
Yes
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
F9089p/100 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 | 803300326608000001SB | 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 92916659-3f5e-48a1-a0d4-f99ed2ec48bb 61 fields · synced Jul 17, 2026
- FDA UDI fcf8a958-bedb-45ec-8194-05df987c617d 36 fields · synced May 30, 2026