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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

DE — IVDR Class A IVDR by Cerascreen GmbH

MD Atlas
Cerascreen GmbH

EUDAMED last updated this device on Nov 9, 2023

DE

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: 04251620705318
Reference / catalog number: DE

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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.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04251620705318
Basic UDI-DI: 42516207001JP
Reference / catalog number: DE
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® Schilddrüsen Test ist ein Probenahme- und Einsendekit zur Ermittlung der Hormone TSH (Thyreotropin), freies T3 (Trijodthyronin) und freies T4 (Thyroxin), die Auskunft über die Schilddrüsenfunktion geben können. Der Test dient der Konzentrationsbestimmung von TSH, fT3 und fT4 in humanem Kapillarblut. Die Probe wird in unserem spezialisierten cerascreen® Diagnostik-Partnerlabor ausgewertet.
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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Expiration date
Manufacturing date
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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.