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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

AC10415 — IVDR Class A IVDR by BIOSYSTEMS S.A.

MD Atlas
BIOSYSTEMS S.A.

EUDAMED last updated this device on Oct 29, 2025

AC10415

8435287190WASHINGSo05P

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: BIOSYSTEMS S.A.
UDI-DI code: 08435287104158
Reference / catalog number: AC10415

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Manufacturer information

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

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Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	May 25, 2022	Still on market
Italy	May 25, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08435287104158
Basic UDI-DI: 8435287190WASHINGSo05P
Reference / catalog number: AC10415
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: See IFU
Additional information URL: https://einfo.bio/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201010185CHEMISTRY ANALYSERS - CONSUMABLES

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

Certificates

Certificate health across this manufacturer's portfolio.

HX 1695779-1Supplemented
Quality management systemNotified body: 0197Expiry: Feb 24, 2030