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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

58100 — Class I MDR by FIAB S.p.A.

MD Atlas
FIAB S.p.A.

EUDAMED last updated this device on Dec 17, 2025

58100

803300326109000002PB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FIAB S.p.A.
UDI-DI code: 18058480753175
Reference / catalog number: 58100

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View device family (Basic UDI)

Manufacturer information

Organization name: FIAB S.p.A.
SRN: IT-MF-000005988
Manufacturer status: Active

Related devices

PG471 /RU4090803300326208000006PROn the market BOSAN/50X90803300326208000006PROn the market FI75140803300326208000006PROn the market EW32D803300326208000006PROn the market PG470W/BEACMED803300326208000006PROn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 18058480753175
Basic UDI-DI: 803300326109000002PB
Reference / catalog number: 58100
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 10
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12050380ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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