If you experience a reportable incident*, you have to fill out this online form . Messages through another delivery path will not be accepted .
Your report will be edited as soon as possible .
* An incident according to "§ 29 Medical device act or § 2 sec.1 Ordinance on Medical Devices Vigilance of Germany " is any malfunction, any failure or deterioration in the characteristics or performance of a medical device as well as any inaccuracy in the labelling or instructions for use which has led, or could have led, directly or indirectly, to the death or serious deterioration in the state of health of a patient or user or another person.
Since 12.03.2021 our products are certified by mdc medical device certification.
In addition to the MDD certificate (directive) as a notified body, it also issues the EN ISO 13485 certificate as a certification body.
Here you can download the certificates:
You can get the current instructions for use (IFU) from your QM contact on request
Phone: +49 7663 91425-0
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