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Amor Gummiwaren GmbH
August-Rost-Straße 4
99310 Arnstadt
Germany
+49(0)3628 66 287 -0
+49(0)3628 66 287 59
Since March 1997, Amor Gummiwaren GmbH has been maintaining a quality management system (QMS) in compliance with DIN EN ISO 9001 and EN ISO 13485:2003 in order to guarantee the permanent meeting of the strict requirements of the law for medical products, being certified by the TÜV-Rheinland Product Safety GmbH (determined authority 0197).
And apart from that, Amor Gummiwaren GmbH has also been certified successfully in compliance with annex II (total quality securing system) of the guideline 93/42/EWG for medical products dated June 14,1993 (EC-guideline medical products) by the TÜV-Rheinland Product Safety GmbH.
Amor Gummiwaren GmbH has met any requirement stipulated by the legislative body and has thus been authorized to distribute its condoms with the label 0197. At the moment, Amor Gummiwaren disposes of its own manufacturing capacity of more than 150 millions of condoms.
Effective as at 01 June, AMOR® Gummiwaren GmbH has acquired major parts of the largest production site for vibrators, lubricants, application vibrators and medical lubricants from the Hungarian BU productions Kft., a subsidiary of the BeateUhse Group.