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Organization name
UDI-DI code
Reference / catalog number

Rapid Influenza A + B Antigen… — IVDD — General IVDD

MD Atlas
MP Biomedicals Germany GmbH

EUDAMED last updated this device on May 26, 2026

Rapid Influenza A + B Antigen Test Card

B-04260163316059

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: 04260163316059
Reference / catalog number: 07FLUA020AG

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View device family (Basic UDI)

Manufacturer information

Organization name: MP Biomedicals Germany GmbH
SRN: DE-MF-000020991
Manufacturer status: Active

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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.

Critical warnings

No critical warnings reported for this device.

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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 Influenza A + B Antigen Test Card
UDI-DI code: 04260163316059
Basic UDI-DI: B-04260163316059
Reference / catalog number: 07FLUA020AG
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: Rapid Influenza A+B Antigen Test Card is an in vitro immunochromatographic assay for the qualitative detection of influenza type A and type B nucleoprotein antigens in nasopharyngeal swab, nasal swab, and nasal aspirate samples. It is intended to aid in the rapid diagnosis of influenza infection. Negative results should be confirmed by other methods, such as cell culture.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

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Expiration date
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Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04260163316059

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0105099004INFLUENZA A AND /OR B - RT & POC

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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