F2017/4fl

EUDAMEDFDA UDI

Class I (EU MDR)

Ref F2017/4FLModel Disposable electrodes for ECG

by FIAB S.p.A.

Identity

Trade Name: NA FDA UDI
Generic Name: Electrocardiographic electrode, single-use FDA UDI
Device Name: Disposable oval-shaped ECG electrodes with liquid gel, Silver/Silver Chloride(SSC) sensor, 52x32mm dimensions and with 4mm socket . These electrodes dimensions have features that make them absolutely reliable during signal recording in rest tests, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording and off-centered configuration allows a better quality of ECG signal and reduces artifacts. They comply with ANSI/AAMI EC12:2000 permitting the signal recovery after defibrillator discharge. After opening, the pouch can be folded to ensure a better preservation of the electrodes that remain inside. The products are latex-free. FDA UDI
Model / Reference: Disposable electrodes for ECG EUDAMED
F2017/4FL EUDAMEDFDA UDI
Description: Disposable oval-shaped ECG electrodes with liquid gel, Silver/Silver Chloride(SSC) sensor, 52x32mm dimensions and with 4mm socket . These electrodes dimensions have features that make them absolutely reliable during signal recording in rest tests, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording and off-centered configuration allows a better quality of ECG signal and reduces artifacts. They comply with ANSI/AAMI EC12:2000 permitting the signal recovery after defibrillator discharge. After opening, the pouch can be folded to ensure a better preservation of the electrodes that remain inside. The products are latex-free. FDA UDI

Identifiers

Catalog Number: F2017/4FL FDA UDI
Primary DI / UDI-DI: 08054953341248 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 EUDAMED
Class II FDA UDI
Regulation Number: 870.2360 FDA UDI
Market of Registration: Italy EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrocardiographic electrode, single-use

F2017/4fl 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

European Union Active

CE/MDR

United States Pending data

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 fcebeb51-3ddb-4cfe-a230-5182e5d3859b 61 fields · synced Jun 18, 2026
FDA UDI 77c65c8f-dbf1-4674-aef7-52f03985205a 36 fields · synced May 30, 2026