F9023plus

EUDAMEDFDA UDI

Class I (EU MDR)

Ref F9023PLUSModel 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 peripheral clamp electrodes for ECG, 20x85mm clamp dimensions. F9023PLUS has features that make it absolutely reliable during signal recording with all different ECG devices on the market.The electrode metallic part is made of silver coated material, allowing a safe and clear signal transmission.The treatment allows the recovery of the signal after defibrillation discharge in compliance with EN60601-2-25 regulation. FIAB peripheral electrodes, thanks to screw and clip connections, can be connected to all ECG devices and monitors with patient cable which have plug or snap connections. The product is latex-free and Nickel-free FDA UDI
Model / Reference: Reusable electrodes for ECG EUDAMED
F9023PLUS EUDAMEDFDA UDI
Description: Reusable peripheral clamp electrodes for ECG, 20x85mm clamp dimensions. F9023PLUS has features that make it absolutely reliable during signal recording with all different ECG devices on the market.The electrode metallic part is made of silver coated material, allowing a safe and clear signal transmission.The treatment allows the recovery of the signal after defibrillation discharge in compliance with EN60601-2-25 regulation. FIAB peripheral electrodes, thanks to screw and clip connections, can be connected to all ECG devices and monitors with patient cable which have plug or snap connections. The product is latex-free and Nickel-free FDA UDI

Identifiers

Catalog Number: F9023PLUS FDA UDI
Primary DI / UDI-DI: 08033003263648 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 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

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

F9023plus by FIAB S.p.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Kendall — Cardinalhealth · Class II

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 d0ea07e2-5d31-41c8-82c9-2bf25938b3d1 61 fields · synced Jun 18, 2026
FDA UDI 0d7194e5-96fe-49b6-a93b-b6d222ec20e2 36 fields · synced May 30, 2026