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Quality Assurance at AGA

At AGA, great emphasis has always been placed on product safety. Our products are developed, manufactured and assembled exclusively in Germany and comply with German and European quality and safety standards.

As early as 1993, part our products received the GS sign (for approved security) by RWTÜV. Since then, the scope of approved products has increased continuously. Nowadays, the GS sign may no longer be attached to medical devices in conjunction with the CE label. 

SSL-6558, SH-1000/LG
BSL-1065/G

CE Conformity

AGA products meet the regulations of EC-Guideline 93/42/EEC of 14 June 1993 concerning medical devices and are thus affixed with the CE label in accordance with Annex VII thereof.

Declaration of EU Conformity - According to EU Council Directive 93/42/EEC

We herewith certify that the design and construction of our products (Class I), as well as the way in which they are brought into commercial circulation by us, are in compliance with the applicable provisions of the EU Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and that the CE label has been affixed to these by us in accordance with Annex VII thereof. Any modification to the products that have not been expressly approved by us shall invalidate the above certification.

Quality Management

QM Certificate for Medical Devices according to DIN EN ISO 13485-2012

In October 1995, AGA Sanitätsartikel GmbH was certified according to DIN EN ISO 9001 - DIN EN 46001 by the Landesgewerbeanstalt Bayern (LGA) as one of the first companies in its field. 

In June 2006, the company received the QM certification for medical devices according to DIN EN ISO 13485:2003, issued by LGA InterCert.

In June 2016, TÜV Rheinland LGA Products GmbH has certified that AGA Sanitätsartikel GmbH has introduced requirements for regulatory purposes in the fields of development, production and distribution of medical furniture and applies a quality management system for medical devices in accordance with DIN EN ISO 13845:2012. The certification has verified that the management system fulfills the requirements of the above standard.

EC Declaration of Conformity
TüV QM Certificate EN ISO 13485:2012
QM Certificate ISO 13485:2012
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+49 (0) 5731 82283

info@agasan.com