Legal Notice; Closing Words - Tec-Innovation INNOMAKE CLIP User Manual

8.

Legal notice

CE-conformity
With the CE marking on the InnoMake clip, we assure that we meet the requirements of the
• EU 2017/745
• 2014/53/EU
• 2011/65/EU
InnoMake Clip is a class 1 medical device.
We, Tec-Innovation GmbH, we have therefore drawn up the declaration of conformity under
our sole responsibility in accordance with Annex VII of the Medical Devices Directive.
Incident reporting
Since this is a medical device, we are legally obligated to point out that all serious incidents
occurring in connection with the product must be reported to the manufacturer, i.e., to us,
Tec-Innovation GmbH, as well as to the responsible authority.
The term "serious" in connection with the use of the InnoMake Clip includes:
the death of a user,

 a life-threatening illness,
the permanent impairment of a bodily function or permanent damage,

a medical or surgical intervention to avert the three aforementioned consequences.


9. Closing words

This is only ONE of our products.
On our website www.tec-innovation.com you can also find information about our other
offers, like
- InnoMake - the seeing shoe
- InnoMake App
One step ahead is not just a slogan!
We wish you a lot of fun, more safety and comfort with the safe InnoMake Clip.
Follow us on:
TDIMC1_4_User Manual_IMC-1.1.0_EN
Regulation of the European Parliament and of the Council of 5
April 2017 concerning medical devices
RED- Directive
RoHS-Directive
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