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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

Action OncoKitDx (Automatic) — IVDD — General IVDD

MD Atlas
Health in Code, S.L.

EUDAMED last updated this device on May 22, 2026

Action OncoKitDx (Automatic)

B-08436589881303

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Health in Code, S.L.
UDI-DI code: 08436589881303
Reference / catalog number: IMG-365

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Manufacturer information

Organization name: Health in Code, S.L.
SRN: ES-MF-000054848
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.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Oct 27, 2020	Still on market

Device identification

Trade name: Action OncoKitDx (Automatic)
UDI-DI code: 08436589881303
Basic UDI-DI: B-08436589881303
Reference / catalog number: IMG-365
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: —
Additional information URL: https://healthincode.com/
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Action PharmaKitDxB-08436589881884On the market DatagenomicsB-08436589881150On the market Haematology OncoKitDxB-08436589881334On the market Hereditary Plus OncoKitDxB-08436589881761On the market HIC MutacionesB-08436589883505On the market

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.