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Product(s江
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Rev01, 2014-12ˉ 19
Ozgur Vicdan
Deputy General Manager
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EC CERTIFICATE
According to Annex V of the Directive 93l42lEEC on Medical Devices
Production Quality Assurance System
Certificate Number:2195ˉMED臼 1130502
Manufacturer: Wuhu Ru刂 in Medica丨 丨nstrument&Device Co Ltd
33Wanchun Rd,VVuhu,China
Final Report No:
MedicaI EIectHc DⅡ
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2195-MED-1111001
Szutest, Notified Body 2195, declares that the aforementioned manufacturer has implemented a quality assurance system according to
Annex V, Section 3 of the directive 93l42|EEC on medical devices This quality assurance system covers those aspects of manufacturing concerned
with securing and maintaining safe conditions of the respective product(s) and conforms to the provisions of this Directive. The approved quality
system is subject to surveillance pursuant to Annex V, Section 4 of Directive 93l42lEEC and unannounced audits.
Szutest must be informed of any significant changes in the design and/or construction of the product(s).
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10ˉ31