Regulatory

Product documents

Streamcheck is a medical device under Regulation (EU) 2017/745. The EU declaration of conformity and the notified body certificate are available here in the original — to view and to download.

Go to the documents

Documents

Declaration of conformity and certificate

We publish these voluntarily. They make the manufacturer, the product covered, the risk class, and the notified body verifiable without having to ask.

EU declaration of conformity

Streamcheck GmbH declares that the Streamcheck system complies with Regulation (EU) 2017/745. The German and English versions are identical in content.

EU quality assurance certificate

Issued by notified body 0494, SLG Prüf- und Zertifizierungs GmbH. It covers quality assurance for the measuring function under Annex XI Part A of the MDR.

Key data

The regulatory details at a glance

All entries are taken from the two documents. The original PDFs prevail.

Manufacturer
Streamcheck GmbH, Arnsdorf 26, 02894 Vierkirchen, Germany
Single registration number (SRN)
DE-MF-000037563
Basic UDI-DI
04262454270002EX
UDI-DI device
4262454270002
UDI-DI app
Android: 4262454270033 · iOS: 4262454270026
Risk class
Class Im — class I with a measuring function
Legal basis
Regulation (EU) 2017/745, Article 52 (7) b in connection with Annex XI Part A
Notified body
0494 — SLG Prüf- und Zertifizierungs GmbH, Hartmannsdorf
Certificate number
111119U5m
Certificate validity
1 October 2025 to 30 September 2030
Technical documentation
Version 4.3, issued 17 September 2025 in Arnsdorf

Intended purpose

Intended purpose and its limits

What Streamcheck is intended for

The Streamcheck system measures and records urine flow parameters and urine biomarkers using standard test strips. The results are displayed to the user in an app and are for information and progress monitoring purposes only.

And what it is not

The system does not provide diagnoses and is not a substitute for a medical examination.

Instructions for use for the device and the app, ways to reach us, and the full manufacturer details:

Instructions for use
Support
Imprint