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F9057prm

EUDAMEDFDA UDI

Class I (EU MDR)

Ref F9057PRMModel 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
F9057PRM model is a disposable round-shaped ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9057PRM is pre-gelled, Ø 32mm, equipped with 50cm long wire and DIN 42802-1 1.5mm socket. The external surface is made of non woven fabric. The fabric is made of plastic polyethylene fiber (and not natural fiber) that guarantees the transpiration of the skin, but at the same time the resistance to liquids with which they may come into contact during their use. Adult and Pediatric model. F9057PRM model 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
F9057PRM EUDAMEDFDA UDI
Description
F9057PRM model is a disposable round-shaped ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9057PRM is pre-gelled, Ø 32mm, equipped with 50cm long wire and DIN 42802-1 1.5mm socket. The external surface is made of non woven fabric. The fabric is made of plastic polyethylene fiber (and not natural fiber) that guarantees the transpiration of the skin, but at the same time the resistance to liquids with which they may come into contact during their use. Adult and Pediatric model. F9057PRM model is radiotranslucent, therefore it allows the user to perform radiographic procedures without removing the electrode. FDA UDI

Identifiers

Catalog Number
F9057PRM FDA UDI
Primary DI / UDI-DI
08054953341064 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

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

F9057prm 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 519eeef4-2bf6-4edb-aaa7-4f3e24899cfe 61 fields · synced Jun 19, 2026
  • FDA UDI 338a21fb-fb57-4e8a-875c-b3133bab37fa 36 fields · synced May 30, 2026