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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

SC-1194 — IVDR Class A IVDR by SCREEN ITALIA S.R.L.

MD Atlas
SCREEN ITALIA S.R.L.

EUDAMED last updated this device on Jun 10, 2025

SC-1194

805901583READERDX

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: SCREEN ITALIA S.R.L.
UDI-DI code: 08059015834591
Reference / catalog number: SC-1194

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View device family (Basic UDI)

Manufacturer information

Organization name: SCREEN ITALIA S.R.L.
SRN: IT-MF-000040460
Manufacturer status: Active

Related devices

SCR0001805901583READERDXOn the market SCR0002805901583READERDXOn the market SC-0869-01805901583READERDXOn the market SC-1194-01805901583READERDXOn the market

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	Jun 1, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08059015834591
Basic UDI-DI: 805901583READERDX
Reference / catalog number: SC-1194
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.screenitalia.it/screen-reader-plus/
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.

W0201069092VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.