Quality document 9

Product Name

EAN/GTIN

Completed by (Name)

Date

Contact information (E-mail)

Type of product

Components/Materials

CE-marked product

YES

NO

Attach the indication and on what standards/requirements

Certified quality system of manufacturer (ISO 13485)

Attach clear Artwork where all the marking is visible (not a product picture on the front only

Does your article or product package contain substances of very high concern from the Candidate List (SVHCs) in a concentration above 0,1% w/w (REACH article 33)?

YES

NO

• List the substances

• If relevant, attach information to allow safe use of the article

• Attach the SCIP number received from the submission of information to the SCIP database of European Chemical Agency (ECHA.)

• If any substance is listed in annex XIV in REACH, attach the authorization

Summary over study/literature – Reference for the effect and claim

Quality document 9

Quality Documentation - Other products