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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

CS-PDL1 — IVDD — General IVDD by CELLS IA TECHNOLOGIES…

MD Atlas
CELLS IA TECHNOLOGIES S.L.

EUDAMED last updated this device on Oct 7, 2025

CS-PDL1

B-08437027144134

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: CELLS IA TECHNOLOGIES S.L.
UDI-DI code: 08437027144134
Reference / catalog number: CS-PDL1 v0.0.0

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Manufacturer information

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

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: CS-PDL1
UDI-DI code: 08437027144134
Basic UDI-DI: B-08437027144134
Reference / catalog number: CS-PDL1 v0.0.0
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The CS-PDL1 algorithm is intended for cancer screening in lung tissue samples: - Detection of cells positive for the PDL1 antibody. - Assists in diagnosing pathological conditions related to the presence of the PDL1 antibody. - Provides specific information about a physiological or pathological state. - A quantitative automated algorithm that integrates Artificial Intelligence. - Uses lung tissue samples from patients of any gender and age. Therefore, the purpose of the algorithm is to provide the pathologist or healthcare professional using it with an automatic identification of findings, facilitating the interpretation of areas with cancer on an image of a processed lung tissue sample. This is achieved by highlighting potential areas of interest so that the pathologist can make a faster and safer diagnosis, less influenced by inter-observer variability since it is standardized. The diagnosis provided by the algorithm is not definitive: it must always be validated by the pathologist, who confirms the accuracy of the generated information.
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

UDI-PI traceability

Batch number
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Software identification

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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.