Certificates and third-party test reports
Every Divous model ships with the compliance file your market requires — EU CE declarations, UK UKCA declarations, FDA registration and SGS testing to the ISO 7176 wheelchair standards.
CE
EU MDR 2017/745, Class I, Annex VIII Rule 13 — with EU authorised representative.
UKCA
UK MDR 2002 Class I with UK responsible person for the British market.
FDA
US FDA establishment registration and device listing for wheelchair products.
ISO 13485:2016
Medical device quality management system covering design and production.
SGS / TUV / BV
Third-party ISO 7176 dimension, stability and strength test reports.
MSDS / UN38.3
Lithium battery safety documentation for air and sea transport.
Original certificates and reports
Click any document to read it full-screen. Signed PDF copies are provided with every order for customs clearance and public tenders.
What SGS actually measured
Report GZHL2401000612MD covers our manual wheelchair platform: seating and wheel dimensions to ISO 7176-7, and static stability forward, rearward and lateral to ISO 7176-1.
Seat width
576 mm
Distance between armrests
583 mm
Backrest angle
79.2°
Seat plane angle
1.8°
Footrest clearance
161 mm
Forward static stability
8.0°
Downhill, brakes locked
8.7°
Lateral static stability
11.9°
Need the signed PDF documents?
Request the full compliance pack from lisahe@divousmedical.com — CE, UKCA, FDA, ISO 13485 and SGS reports for your model.