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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

18 — IVDR Class B IVDR by Home Diagnostics S.L

MD Atlas
Home Diagnostics S.L

EUDAMED last updated this device on Apr 17, 2026

18

843702490918EZ

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Home Diagnostics S.L
UDI-DI code: 08437024909187
Reference / catalog number: 18

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Manufacturer information

Organization name: Home Diagnostics S.L
SRN: ES-MF-000026858
Manufacturer status: Active

Related devices

01843702490901EGOn the market 02843702490902EJOn the market 04843702490904ENOn the market REFERENCIA 14843702490914EROn the market REFERENCIA 11843702490911EKOn 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.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Nov 27, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08437024909187
Basic UDI-DI: 843702490918EZ
Reference / catalog number: 18
Issuing entity: GS1

Classification

Risk category: IVDR Class B
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Ailin OS es una plataforma software IVD standalone (IVD MDSW), clasificada como Clase B bajo el IVDR 2017/746 (Regla 6, Anexo VIII). Su función es integrar resultados analíticos procedentes de laboratorios clínicos acreditados externos con datos estructurados de salud y estilo de vida recogidos mediante cuestionarios, para generar perfiles clínicos personalizados basados en contenido médicamente validado.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02060292POST-ANALYSIS SAMPLE ARCHIVING SYSTEMS - IVD MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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