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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

99040005 — IVDR Class A IVDR by Cerascreen GmbH

MD Atlas
Cerascreen GmbH

EUDAMED last updated this device on Apr 2, 2026

99040005

42516207001JP

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Cerascreen GmbH
UDI-DI code: 04251620700320
Reference / catalog number: 99040005

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Manufacturer information

Organization name: Cerascreen GmbH
SRN: DE-MF-000017602
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Nov 1, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04251620700320
Basic UDI-DI: 42516207001JP
Reference / catalog number: 99040005
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Der cerascreen® Unverträglichkeits-Check Plus ist ein Probenahme- und Einsendekit, das erste Anhaltspunkt für mögliche Lebensmittelallergien und Unverträglichkeiten*, eine Histamin-Intoleranz und eine Gluten-Unverträglichkeit (Zöliakie) liefert. Der Test dient zur Bestimmung von spezifischen IgE und IgG4, dem Histamin-abbauenden Enzym Diaminoxidase (DAO) sowie der Zöliakie-typischen Antikörper gegen Gewebs-Transglutaminase (tTg-IgG) in humanem Kapillarblut. Unverträglichkeiten können sofort oder verzögert und bereits durch kleinste Mengen eines Lebensmittels ausgelöst werden. Bei dem Unverträglichkeits-Check Plus werden die häufigsten Ursachen abgeklärt.
Additional information URL: https://cerascreen.info/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0501010201CAPILLARY BLOOD COLLECTION SYSTEMS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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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.