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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

99010552 — IVDR Class A IVDR by Cerascreen GmbH

MD Atlas
Cerascreen GmbH

EUDAMED last updated this device on Nov 17, 2023

99010552

42516207002JR

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: 04251620707640
Reference / catalog number: 99010552

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Manufacturer information

Organization name: Cerascreen GmbH
SRN: DE-MF-000017602
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.

Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement	May 1, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04251620707640
Basic UDI-DI: 42516207002JR
Reference / catalog number: 99010552
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® PSA Test ist ein Probenahme- und Einsendekit zur Bestimmung des prostataspezifischen Antigens. Lassen Sie die Konzentration von PSA in Ihrem Blut bestimmen und erhalten Sie damit einen ersten Anhaltspunkt für die Gesundheit Ihrer Prostata.
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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