EU Declaration of Conformity
Document Reference: F MDR A-IV
Issue Date: 2025-05-05
Technical Documentation: AeroWalk™ Carbon
Form Revision: Rev. 1.0
EU DECLARATION OF CONFORMITY
[CE Mark]
| Name and address of the firm | Single Registration Number (SRN) |
|---|---|
| Drive Medical GmbH & Co. KG Leutkircher Straße 44 DE-88316 Isny/Allgäu |
DE-MF-000006420 |
Manufacturer's Declaration
We, as the manufacturer, declare that we have issued this EU declaration of conformity under our sole responsibility and that the medical device with its intended purpose:
Product: AeroWalk™ Carbon
- REF 720200010 - AeroWalk™ Carbon / Racing green
- REF 720200020 - AeroWalk™ Carbon / Graphite grey
- REF 720200030 - AeroWalk™ Carbon / Fire red
- REF 720200040 - AeroWalk™ Carbon / Butter Cream
Intended Purpose
The AeroWalk™ Carbon rollator is used to support safe walking.
Compliance Details
| According to the revision of the technical documentation | With the Basic UDI-DI | Of class |
|---|---|---|
| 2025-05-05 | 4065995Aerowalkcarb3T | 1 (according to annex VIII of MDR 2017/745 - rule) |
Meets all the provisions of the MDR 2017/745 which apply to it.
Applied Standards
- DIN EN ISO 13485:2021
- DIN EN ISO 11199-2:2025
- DIN EN ISO 21856:2022
- DIN EN 1021-1/-2:2014
- DIN EN ISO 10993-1:2021
- DIN EN 62366-1:2021
- DIN EN ISO 14971:2022
Conformity Assessment and Validity
Conformity assessment procedure: MDR Art. 52 & Annex II, III (Class I)
Declaration's validity: 2 years after signing or changes to the technical documentation.
Signatory Information
Place, date and function: O. Niemann, Geschäftsführer
[Signature and Stamp]
Created: N. Pfiffner, 2025-03-25
Approved: F. Stech, 2025-03-25
