<p> [TO BE PRINTED ON ORIGINAL COMPANY LETTERHEAD]</p><p>Declaration of Conformity</p><p>PRODUCT IDENTIFICATION Product Name Model/Number Name of your device(s) Model name(s) and/or catalog number(s)</p><p>MANUFACTURER Name of Company Address Representative Official company name Address Name of company Quality City, state/province Management Representative Zip/post code Country</p><p>AUTHORIZED REPRESENTATIVE Name of Company Address Telephone/email Emergo Europe Prinsessegracht 20 +31.70.345.8570 - phone 2514 AP The Hague +31.70.346.7299 - fax The Netherlands [email protected]</p><p>REGISTRATION INFORMATION Notified Body and ID # CE certificate number</p><p>CONFORMITY ASSESSMENT Device Classification Route to Compliance Standards Applied Class: Annex II List A, or Annex ___ of IVDD Optional Annex II List B, or Self- 98/79/EC Council Test Directive</p><p>[Manufacturer name] declares that the above mentioned products meet the provision of the Council Directive 98/79/EC for In Vitro Diagnostic Medical Devices and Directive 98/79/EC as transposed in the national laws of the Member States.</p><p>COMPANY REPRESENTATIVE: Senior level management representing company</p><p>TITLE: Title of the senior level official SIGNATURE: </p><p>Page 1 of 2 </p><p>Form 7.5-1-7-5, Rev. 0 DATE: European format DD/MM/YYYY </p><p>Page 2 of 2 </p><p>Form 7.5-1-7-5, Rev. 0</p>