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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

SARA_Gen2 — IVDR Class A IVDR by DIA.PRO DIAGNOSTIC…

MD Atlas
DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.

EUDAMED last updated this device on May 4, 2026

SARA_Gen2

805061604INCS99

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
UDI-DI code: 08050616042767
Reference / catalog number: SARA_Gen2

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View device family (Basic UDI)

Manufacturer information

Organization name: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
SRN: IT-MF-000029123
Manufacturer status: Active

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Dengue virus NS1 AgB-08050616042262On the market DP5805061604INE57MOn the market HEV IgMB-08050616040183On the market Parvovirus B19 IgMB-08050616041036On the market SARA805061604INCS99On the market

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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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: 08050616042767
Basic UDI-DI: 805061604INCS99
Reference / catalog number: SARA_Gen2
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: 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

UDI-DI DataMatrix

Encoded

(01)08050616042767

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

W0201020102AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)

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.