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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

Rapid SARS-CoV-2 Antigen Test Card — IVDD — General IVDD

MD Atlas
MP Biomedicals Germany GmbH

EUDAMED last updated this device on May 19, 2026

Rapid SARS-CoV-2 Antigen Test Card

B-04260163315601

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: MP Biomedicals Germany GmbH
UDI-DI code: 04260163315601
Reference / catalog number: 07AG6020B

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Manufacturer information

Organization name: MP Biomedicals Germany GmbH
SRN: DE-MF-000020991
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 Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: Rapid SARS-CoV-2 Antigen Test Card
UDI-DI code: 04260163315601
Basic UDI-DI: B-04260163315601
Reference / catalog number: 07AG6020B
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: ► For In Vitro Diagnostic Use Only INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in nasal swabs, nasopharyngeal swabs or oropharyngeal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card cannot be used as the sole basis to diagnose or exclude SARS-CoV-2 infection. Rapid SARS-CoV-2 Antigen Test Card detects the SARS-CoV-2 nucleocapsid protein (N protein). Theoretically, genetic SARS-CoV-2 variants with non-nucleocapsid protein mutations do not affect the product performance.
Additional information URL: No additional information URL provided by the manufacturer.
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
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Software identification

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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.