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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

NucleIQ — IVDR Class A IVDR by CELLS IA TECHNOLOGIES…

MD Atlas
CELLS IA TECHNOLOGIES S.L.

EUDAMED last updated this device on Oct 7, 2025

NucleIQ

8437027144PLATFORM7W

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: CELLS IA TECHNOLOGIES S.L.
UDI-DI code: 08437027144172
Reference / catalog number: NucleIQ v1.0.0

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Manufacturer information

Organization name: CELLS IA TECHNOLOGIES S.L.
SRN: ES-MF-000042517
Manufacturer status: Active

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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.

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: NucleIQ
UDI-DI code: 08437027144172
Basic UDI-DI: 8437027144PLATFORM7W
Reference / catalog number: NucleIQ v1.0.0
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: NucleIQ is a general-purpose digital pathology software platform intended for in vitro diagnostic use by qualified healthcare professionals within clinical laboratory settings. The platform is designed to support the digital review of histopathological specimens by enabling the visualization, navigation, annotation, measurement, and case validation of digitized Whole Slide Images (WSIs), obtained from stained human tissue samples. The platform facilitates qualitative and quantitative assessments of pathology slides as part of diagnostic workflows in anatomical pathology. NucleIQ may optionally display results from separately certified Artificial Intelligence (AI) modules, which are integrated to assist clinical users in the diagnostic process. NucleIQ supports integration with Laboratory Information Systems (LIS) to improve workflow efficiency, enable case tracking, and streamline case validation and reporting. Use of the platform is intended to enhance pathologist review processes and reduce time to diagnosis through digital visualization capabilities.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02069092VARIOUS SAMPLE PROCESSING INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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