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F9046rm

EUDAMEDFDA UDI

Class I (EU MDR)

Ref F9046RMModel 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 ECG RADIOLUCENT electrodes with solid gel, 28x44mm dimensions, Silver/Silver Chloride(SSC) sensor and carbon snap. F9046RM model is 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. The peculiar feature of the electrode is the carbon snap that makes it radiolucent. Neither of the components contains any ferromagnetic materials, therefore the electrodes are fully compatible with MRI applications. The electrodes are MRI tested for use up to 3 T electro-magnetic field. The use of the electrodes do not affect the safety and functioning of Magnetic Resonance Imaging Systems. 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 EUDAMED
F9046RM EUDAMEDFDA UDI
Description
Disposable ECG RADIOLUCENT electrodes with solid gel, 28x44mm dimensions, Silver/Silver Chloride(SSC) sensor and carbon snap. F9046RM model is 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. The peculiar feature of the electrode is the carbon snap that makes it radiolucent. Neither of the components contains any ferromagnetic materials, therefore the electrodes are fully compatible with MRI applications. The electrodes are MRI tested for use up to 3 T electro-magnetic field. The use of the electrodes do not affect the safety and functioning of Magnetic Resonance Imaging Systems. 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
F9046RM FDA UDI
Primary DI / UDI-DI
08054953343495 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

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrocardiographic electrode, single-use

F9046rm by FIAB S.p.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic electrode, single-use.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FIAB S.p.A.
EUDAMED SRN
IT-MF-000005988

Sources (2)

  • EUDAMED 8844d25a-b895-47f6-adab-9b7c8f4557be 61 fields · synced Jul 8, 2026
  • FDA UDI d26d7084-dd8a-4f64-a82e-9bbe428d5138 36 fields · synced May 30, 2026