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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

OD002 — IVDD — General IVDD by OncoDNA

MD Atlas
OncoDNA

EUDAMED last updated this device on Jan 20, 2026

OD002

B-05430003021576

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: OncoDNA
UDI-DI code: 05430003021576
Reference / catalog number: OD002

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Manufacturer information

Organization name: OncoDNA
SRN: BE-MF-000021570
Manufacturer status: Active

Market distribution

Primary placement in Belgium; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05430003021576
Basic UDI-DI: B-05430003021576
Reference / catalog number: OD002
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: OncoDEEP Kit is a comprehensive molecular profiling assay able to identify all biomarkers required for the prescription of approved biomarker associated therapies, as well as guiding choice of chemotherapy and highlighting potential. clinical trial options The OncoDEEP kit is intended to be used by laboratory professionals with a background in molecular biology and Next Generation Sequencing (lab technicians, biologists). Patients have no contact with the device. The device must be used in a laboratory environment with appropriate measures to prevent any contamination of the sample or its byproduct during the analysis process.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Manufacturing date
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Software identification

Related devices

This device is not currently linked to any other device.

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.