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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

PATHOX — IVDR Class A IVDR by Tesi Elettronica e…

MD Atlas
Tesi Elettronica e Sistemi Informativi S.p.A.

EUDAMED last updated this device on May 4, 2026

PATHOX

805577403PATHOXKY

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Tesi Elettronica e Sistemi Informativi S.p.A.
UDI-DI code: 08055774030120
Reference / catalog number: PATHOX

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View device family (Basic UDI)

Manufacturer information

Organization name: Tesi Elettronica e Sistemi Informativi S.p.A.
SRN: IT-MF-000021278
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

IT339901Issued
Quality management systemNotified body: 1370Expiry: Feb 6, 2030

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 2 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Malta		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08055774030120
Basic UDI-DI: 805577403PATHOXKY
Reference / catalog number: PATHOX
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)08055774030120

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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.

W02079092VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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