F9053pr/10
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 monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9053PR/10 model is oval-shaped electrodes, 20x15mm dimensions, equipped with 10cm long wire and 4mm socket, pre-gelled and they can be easily connected to the ECG monitor, avoiding pressure on the skin. 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 ECG electrodes with connection cable EUDAMEDF9053PR/10 EUDAMEDFDA UDI
- Description
- Disposable ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9053PR/10 model is oval-shaped electrodes, 20x15mm dimensions, equipped with 10cm long wire and 4mm socket, pre-gelled and they can be easily connected to the ECG monitor, avoiding pressure on the skin. 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
- F9053PR/10 FDA UDI
- Primary DI / UDI-DI
- 08054242442267 EUDAMEDFDA UDI
- Basic UDI-DI
- 803300326608000002SD 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
F9053pr/10 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 | 803300326608000002SD | 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 5a6e86c0-b2a5-46e0-8545-039400afc148 61 fields · synced Jun 18, 2026
- FDA UDI 7c672679-d753-410d-b8c8-f23036647fd4 36 fields · synced May 30, 2026