General; Manufacturer; Hotline; Adverse Incident Reporting Requirement - KLS Martin group Kit de préparation des fibres stérilisable Mode D'emploi

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  • FRANÇAIS, page 53

1 General

1.1

Manufacturer

Thank you for choosing a KLS Martin product.
This product has the CE mark, which means that it is compliant with the essential safety and performance
requirements for medical devices pursuant to applicable European regulations.
We are the manufacturer of this product:
Gebrüder Martin GmbH + Co. KG
A comany of the KLS Martin Group
KLS Martin Platz 1 · D-78532 Tuttlingen · Germany
Tel. +49 7461 706-0 · Fax +49 7461 706-193
info@klsmartin.com · www.klsmartin.com
1.2

Hotline

If you have questions about how to use this device or product or questions about clinical applications,
please contact the product management team:
Tel:
+49 7461 706-243
Fax:
+49 7461 706-190
If you have technical questions or questions about maintenance contracts and training, please contact the
Martin Service Center:
Tel:
+49 7461 706-343
Fax:
+49 7461 706-484
Email: service@klsmartin.com
The entire set and the individual components are labeled with a lot (LOT) and a catalogue number (REF).
When making a product complaint, please include the LOT and REF.
1.3

Adverse incident reporting requirement

All serious incidents occurring in connection with the product shall be reported immediately to us and to
the competent authority.
24
Sterilizable Fiber Preparation Set
Instructions for Use
Revision 03

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