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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

99010471 — IVDR Class A IVDR by Cerascreen GmbH

MD Atlas
Cerascreen GmbH

EUDAMED last updated this device on Oct 10, 2023

99010471

42516207003JT

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: 04251620709248
Reference / catalog number: 99010471

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Manufacturer information

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

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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: 04251620709248
Basic UDI-DI: 42516207003JT
Reference / catalog number: 99010471
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® STI Test XL ist ein Probenahme- und Einsendekit zur Bestimmung von Erregern von sexuell übertragbaren Krankheiten (STI). Der Test dient dem Nachweis von Erregern in Ihrem Erststrahlurin, die zu sexuell übertragbaren Krankheiten führen können.
Additional information URL: https://cerascreen.info/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05010202URINE COLLECTION, TUBES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.