F-7 5-1-7-5 Doc IVD-Annexii List a B-Selftest

[TO BE PRINTED ON ORIGINAL COMPANY LETTERHEAD]

Declaration of Conformity

PRODUCT IDENTIFICATION Product Name Model/Number Name of your device(s) Model name(s) and/or catalog number(s)

MANUFACTURER Name of Company Address Representative Official company name Address Name of company Quality City, state/province Management Representative Zip/post code Country

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]

REGISTRATION INFORMATION Notified Body and ID # CE certificate number

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

[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.

COMPANY REPRESENTATIVE: Senior level management representing company

TITLE: Title of the senior level official SIGNATURE:

Form 7.5-1-7-5, Rev. 0 DATE: European format DD/MM/YYYY

Form 7.5-1-7-5, Rev. 0