iPeeWell Certificates
At iPeeWell, quality, safety, and regulatory compliance are not just formal requirements. They are part of how we design, manufacture, and deliver our uroflowmetry solution.
On this page, you can view our key certificates related to medical device compliance and quality management.
| MDR Certificate – EU 2017/745 (medical device certification) | ISO 13485:2016 Certificate |
| The MDR certificate confirms that the iPeeWell Uroflowmeter is assessed under the applicable European medical device regulatory framework. | ISO 13485 is an internationally recognized quality management system standard for organizations involved in medical devices. It supports consistent processes, documentation, traceability, and quality control. |
| Certificate number: MDR-QMS-0009-N20260324 Issued by: Notice d.o.o., Dunajska cesta 156, 1000 Ljubljana, Slovenija – Notified body No. 3121 Valid until: 2031-03-23 | Certificate number: MD-0009-N20260324 Issued by: Notice d.o.o., Dunajska cesta 156, 1000 Ljubljana, Slovenija – Notified body No. 3121 Valid until: 2029-03-23 |
 iPeeWell MDR certificate for the iPeeWell Uroflowmeter – EU 2017/745 |  iPeeWell ISO 13485 certificate for medical device quality management – ISO13485:2016 |
Why this matters?
Healthcare professionals, distributors, and patients need to know that medical technology is developed and supplied responsibly. Our certificates reflect our commitment to quality, safety, and regulatory compliance.
For additional documentation or partner inquiries, please contact us.