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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

61012 — IVDD — General IVDD by BIOSYSTEMS S.A.

MD Atlas
BIOSYSTEMS S.A.

EUDAMED last updated this device on Nov 17, 2025

61012

B-08435287112177

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: BIOSYSTEMS S.A.
UDI-DI code: 08435287112177
Reference / catalog number: 61012

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Manufacturer information

Organization name: BIOSYSTEMS S.A.
SRN: ES-MF-000000231
Manufacturer status: Active

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31100B-08435287111002On the market 31107B-08435287111071On the market 22340B-08435287112023On the market 31014B-08435287110142On the market 31086B-08435287110869On 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 2 countries total.

Country	On market since	Until
SpainPrimary placement	Feb 1, 2022	Still on market
Romania	Feb 1, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08435287112177
Basic UDI-DI: B-08435287112177
Reference / catalog number: 61012
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: See IFU (section intended use)
Additional information URL: https://einfo.bio/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103010599HAEMATOLOGY CONTROLS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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