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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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Rapid SARS-CoV-2 Antigen Test Card — 1 UDI-DI variant, IVDD

MD Atlas
MP Biomedicals Germany GmbH

Data from EUDAMED, last updated May 31, 2026

Rapid SARS-CoV-2 Antigen Test Card

B-04260163315991

1 UDI-DI variant

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]IVDD — General

Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Manufacturer: MP Biomedicals Germany GmbH

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Device characteristics

ReagentSelf-testingAnimal tissues / cells

Identity & classification

Basic UDI-DI: B-04260163315991
Device name: Rapid SARS-CoV-2 Antigen Test Card
Issuing agency: EUDAMED
Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Version date: May 26, 2026

Manufacturer & authorised representative

Manufacturer

Name: MP Biomedicals Germany GmbH
SRN: DE-MF-000020991
Country: Germany
Email: diagnostics@mpbio.com
Phone: +49 5651 921 0

Variants by status

UDI-DI variants

1 UDI-DI variant

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Export results

Applied filters

basicUdiUlid01KSJ81ER2YFJWX5KY1634TGQS

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Rapid SARS-CoV-2 Antigen Test Card04260163315991