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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

DNLAB IVD CORE — IVDR Class A IVDR by Dedalus Italia SpA

MD Atlas
Dedalus Italia SpA

EUDAMED last updated this device on Oct 28, 2025

DNLAB IVD CORE

805572803DNLABIVDCORES6

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Dedalus Italia SpA
UDI-DI code: 08055728030480
Reference / catalog number: DNLAB IVD CORE

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View device family (Basic UDI)

Manufacturer information

Organization name: Dedalus Italia SpA
SRN: IT-MF-000009127
Manufacturer status: Active

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.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08055728030480
Basic UDI-DI: 805572803DNLABIVDCORES6
Reference / catalog number: DNLAB IVD CORE
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: DNLab IVD CORE supporta il personale di laboratorio analisi, microbiologia e genetica nella gestione del ciclo di vita degli esami e nella produzione dei risultati. Il sistema consente di: • Inserire i risultati degli esami in forma numerica, testuale o sotto forma di sigle • Consultare i risultati fornendo confronti con valori di soglia di riferimento ed in forma grafica • Validare i risultati mediante un sistema a due livelli: livello tecnico e clinico • Produrre referti supportando il personale nella loro compilazione mediante cataloghi predefiniti
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)08055728030480

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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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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.