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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 Zika Virus IgG/IgM Combo… — IVDD — General IVDD

MD Atlas
MP Biomedicals Germany GmbH

EUDAMED last updated this device on May 27, 2026

Rapid Zika Virus IgG/IgM Combo Test Card

B-04260163316066

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: 04260163316066
Reference / catalog number: 07ZIKA001AB

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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 Zika Virus IgG/IgM Combo Test Card
UDI-DI code: 04260163316066
Basic UDI-DI: B-04260163316066
Reference / catalog number: 07ZIKA001AB
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 Zika Virus IgG/IgM Combo Test Card is a rapid immunochromatographic assay for the simultaneous detection of IgG and IgM antibodies to Zika virus in human whole blood, serum or plasma. The assay is intended for diagnostic use only.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

W0105040630ZIKA VIRUS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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