Get Zoll Declares That The Above Products Conform To - Merplast

Filling out the ZOLL Declares That The Above Products Conform To - Merplast form is an essential task for ensuring compliance with regulatory standards for medical devices. This comprehensive guide will assist you in completing the form thoroughly and accurately.

Follow the steps to successfully complete the form.

1. Click the ‘Get Form’ button to obtain the form and open it in the designated online editor.
2. Begin by entering the name of the manufacturer, which is ZOLL Medical Corporation, followed by their address: 269 Mill Road, Chelmsford, MA 01824-4105 USA.
3. Next, include the name and address of the international holding company, ZOLL International Holding B.V., located at Newtonweg 18, 6662 PV ELST, The Netherlands.
4. Identify the product names being declared. Ensure to list all applicable products, such as ZOLL AED Plus®, ZOLL AED Plus Fully Automatic, and ZOLL AED Plus Accessories.
5. Indicate the compliance statement by confirming that the products conform to the European Council Directive 93/42/EEC (Medical Device Directive) class IIb per rule 9 of Annex IX.
6. Document any certification numbers associated with the products. Include the provided certificates: Q1N 1204 79546 002 and G1 1204 79546 003.
7. Fill in the declaration date, which is 6 June 2012, to finalize the date of issuance.
8. Sign the document with the name and title of the authorized person, in this case, Paul Dias, Vice President of QA & RA.
9. Finally, review all filled information for accuracy before saving, downloading, printing, or sharing the completed form.

Complete your documents online today for regulatory compliance.