F9009ultra

EUDAMEDFDA UDI

Class I (EU MDR)

Ref F9009ULTRAModel 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 praecordial suction chest electrodes for ECG, rubber ring diameter Ø 24mm and electrode diameter Ø 14mm. F9009ULTRA model has features that make it absolutely reliable during signal recording with all different ECG devices on the market. The plastic metallic part is silver coated (Ag/AgCl) 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 suction chest electrodes thanks toelastic connections, can be tapped to all ECG devices and monitors with patient cables which have 4mm plug connections. The product is Latex-free and Nickel-free. FDA UDI
Model / Reference: Reusable electrodes for ECG EUDAMED
F9009ULTRA EUDAMEDFDA UDI
Description: Reusable praecordial suction chest electrodes for ECG, rubber ring diameter Ø 24mm and electrode diameter Ø 14mm. F9009ULTRA model has features that make it absolutely reliable during signal recording with all different ECG devices on the market. The plastic metallic part is silver coated (Ag/AgCl) 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 suction chest electrodes thanks toelastic connections, can be tapped to all ECG devices and monitors with patient cables which have 4mm plug connections. The product is Latex-free and Nickel-free. FDA UDI

Identifiers

Catalog Number: F9009ULTRA FDA UDI
Primary DI / UDI-DI: 08033003262887 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

F9009ultra 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	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 9332ead4-696e-44d8-8503-59764a9f50aa 61 fields · synced Jul 13, 2026
FDA UDI 250c25ef-0ae1-4e12-b7ba-b42452c9bbe5 36 fields · synced May 30, 2026