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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

859258 — IVDD — Self-testing IVDD by BIOSYNEX Swiss SA

MD Atlas
BIOSYNEX Swiss SA

EUDAMED last updated this device on Apr 27, 2026

859258

B-03532678592589

On the marketIVDD — Self-testing

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: BIOSYNEX Swiss SA
UDI-DI code: 03532678592589
Reference / catalog number: 859258

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Manufacturer information

Organization name: BIOSYNEX Swiss SA
SRN: CH-MF-000024717
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 France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03532678592589
Basic UDI-DI: B-03532678592589
Reference / catalog number: 859258
Issuing entity: GS1

Classification

Risk category: IVDD — Self-testing
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Detection of SARS-CoV-2 antigens.Test to be used for self-diagnosis.
Additional information URL: https://www.biosynex.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105090501CORONAVIRUS ANTIGEN (AG) - RT & POC

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

859263B-03532678592633On the market 859261B-03532678592619On the market 859257B-03532678592572On the market 859385B-03532678593852On the market 859262B-03532678592626On 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.