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Dear Sirs, we are lookijng for FFP masks. Now we need your following documents for theFFP masks: ISO 13458-2012 CE-Annex Zertifikate Declarationof conformity Instruction for use Technical Datasheet Essential Requirements, Annex I, acc. 93/42 EEC Risk-analysis acc. ISO 14971 (required in Annex I, acc.93/42 EEC) Clinical Evaluation acc. Annex X (required in Annex X, acc. 93/42 EEC) note: point 1.1b of the Annex X and point 6a. of the Annex I) Biocompatibility Test (acc 10993-1, 10993-5 and 10993-10, required in Annex I of directive 93/42 EEC), note: point 7. of the Annex I) Proof of Authorized European Representative (Contract or Certificate as legal proof ) Notification to the competent authority (done by the Authorized European Representative) Dolomite Dust TestPlease contact us, directly with E-MAIL... Best regards Rasit Tirman Projectmanagement BODY PRODUCTS RELAX Pharma und Kosmetik GmbH Gewerbepark West - Alfred-Nobel-Strasse 1 3 D-50226 Frechen Germany Telefon: +49 2234 - 91165-41 Telefax: +49 2234 - 91165-23 Mobil: +49 151-***81 Skype: rasit***
