5824523221

Certificate

Tho Ccrtification Body of TUV Rheinland Product Safety GmbH

hcrcby ccrtifios that thc orgamzation

BALTON Sp. z o.o. ul. Nowy Świat 7/14 00-496 Warszawa Poland has estabtisbed and appties a cjuatily management system for medical devices for tho following soopo:

Design and dovolopmont. production and distribution of medical dcviccs

(see attachment for products and sites included)

Proof has been furnished that the reguroments spcdficd in

EN ISO 13485:2003 + AC:2007

aro fulfillcd. The quelity management system is subjcct to ycarly survcillonce.

Certificate Registration No.:    SX 60027692 0001

An audit was performed. Report No.: 26300066 002 This Certificate »s vai»d until:    23.11.2014

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Cologne. 24.11.2009

TUV Rheinland Product Safety GmbH - Am Grauen Stein - D-51105 Koln

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