TNO CERTIFICATION
CE-Certificate
Medical Devices
Issued to:
EPKON International Enterprises B.V.
Vilvoordehof 1, 5628 TG, Eindhoven, The Netherlands

for Class lla products falling in the category:
Autogravitatische Behandelbank Gravitiser

This certificate is based on the Delivery Conditions of TNO Certification and the Certification History Documentation CHD20119.01.

TNO Certification, in its capacity as a Notified Body for Medical Devices, hereby certifies that a conformity assessment of the Class IIa products falling within the product category mentioned above has been carried out in accordance with the relevant provisions of the Council Directive 93/42/EEC concerning medical devices, following Annex VI in combination with Annex VII of this Directive. The examination of the product quality assurance system has been carried out following the requirements of the national legislation to which TNO Certification is subjected. The Certification History Documentation contains information about the products concerned and refers to the documentation containing information about the products and the examinations performed. This Certificate is valid for three years under the delivery conditions.
EPKON  Enterprises International B.V. has the right to use the Notified Body Identification Number 0336 in conjunction with the CE-mark on the products falling within the product category mentioned above and meeting the relevant provisions of the Directive. This Certificate is issued on May 22, 2006 and expires on May 21, 2009.

R.G.M. van Melick, Pharm. D. Director Medical TNO Certification B.V.

TNO Certification; P.O. Box 6080; 2600 JA Delft; The Netherlands

Certificate number: CE20119.01
CEVIIVI2a.R4

Quality standards and qualifications.

The President of Epkon has bound himself to act according to the quality control stated in attachment VI of guideline 93/42/EEG and to which the standards of NEN-EN-ISO 13485:2003 apply.