Safety

Reporting Medical Incidents

To ensure the safety of users of our medical devices and as part of our post-market safety surveillance, we collect information regarding incidents and serious medical incidents related to Biofaktor Sp. z o.o. medical devices.

If such an incident occurs or is suspected, please report it immediately to our Safety Monitoring Department.

Information on Personal Data Protection

Reports can also be submitted to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

By submitting a medical incident report, you consent to the processing of your personal data to the extent necessary to receive, register, and analyze the report, in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (GDPR).

By mail

Biofaktor Sp. z o.o.
al. KEN 55/28 KEN 55/28,
02-797 Warszawa, Poland

By e-mail

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