F9053rm/80

EUDAMEDFDA UDI

Class I (EU MDR)

Ref F9053RM/80Model Disposable ECG electrodes with connection cable

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). F9053RM/80 model is round-shaped electrodes, Ø 32mm, equipped with 80cm long wire and 4mm socket, pre-gelled and it 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. F9053RM/80 is radiotranslucent, therefore it allows the user to perform radiographic procedures without removing the electrode. FDA UDI
Model / Reference: Disposable ECG electrodes with connection cable EUDAMED
F9053RM/80 EUDAMEDFDA UDI
Description: Disposable ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9053RM/80 model is round-shaped electrodes, Ø 32mm, equipped with 80cm long wire and 4mm socket, pre-gelled and it 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. F9053RM/80 is radiotranslucent, therefore it allows the user to perform radiographic procedures without removing the electrode. FDA UDI

Identifiers

Catalog Number: F9053RM/80 FDA UDI
Primary DI / UDI-DI: 08033695728234 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 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

F9053rm/80 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	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 21da457e-6f57-4a07-b51f-73267e66c0ec 61 fields · synced Jun 17, 2026
FDA UDI 54941ede-2eea-49c7-9445-f79071c7fe1f 36 fields · synced May 30, 2026