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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

99010475 — IVDR Class A IVDR by Cerascreen GmbH

MD Atlas
Cerascreen GmbH

EUDAMED last updated this device on Oct 18, 2023

99010475

42516207004JV

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: 04251620706797
Reference / catalog number: 99010475

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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	May 1, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04251620706797
Basic UDI-DI: 42516207004JV
Reference / catalog number: 99010475
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® Helicobacter pylori Test ist ein Probenahme- und Einsendekit für eine Stuhluntersuchung. Der Test dient der Bestimmung von Antigenen, die einen Hinweis auf eine mögliche Infektion mit dem Bakterium Helicobacter pylori im Magen geben können.
Additional information URL: https://cerascreen.info/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05019001FAECES COLLECTION DEVICES

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.