S 4 ° z = eA wi ro) Bd S) =) = S rs E eA wi re) oa e 3 3 = e = - a wi ) ° i Bal Fa ZERTIFIKAT ® CERTIFICATE @ pane Nee eat tLe Coes see f Simms | eH areas 244.10.08 EC Certificate Production Quality Assurance System Directive 93/42/EEC on Medical Devices (MDD), Annex V (Devices in class | in sterile conditions, sterilised systems or procedure packs) No. G2S 092387 0002 Rev. 00 Product Serve Manufacturer Suzhou Vicon Industrial Co., Ltd. NO.11, Shitian Road, Yangchenghu Town Xiangcheng District 218122 Suzhou, Jiangsu PEOPLE'S REPUBLIC OF CHINA EC-Representative: Shanghai International Holding Corp. GmbH (Europe) EiffestraBe 80, 20537 Hamburg, GERMANY Product Sterile Eye Pad, Sterile First-aid Dressing Bandage, ies): Sterile Wound Plaster (Sterile Plaster Strips, Sterile ies): Category(ies) ‘Adhesive Wound Dressing), Sterile Non-adherent Dressing, Sterile Gauze Swab, Disposable Sterile Gown, Disposable Sterile Drape, Basic Dressing Pack, First Aid Kits, Sterile Non-woven Swabs. The Certification Body of TUV SUD Product Service GmbH declares that the aforementioned manufacturer has implemented a quality assurance system for manufacture in accordance with MDD Annex V. This quality assurance system covers those aspects of manufacture concemed with securing and maintaining sterile conditions of the respective devices / device categories and conforms to the requirements of this Directive. Itis subject to periodical surveillance. See also notes overleaf. Report No.: SH1811319 Valid from: 2019-02-14 Valid until: 2023-03-11 Date, 2019-02-14 I h. yf Stefan Preit Page 1 of2 ‘TOV SUD Product Service GmbH is Notified Body with identification no. 0123, ‘TOV SUD Product Service GmbH + Certification Body + Ridlerstrafte 65 + 60339 Munich » Germanys es S ree = a rr) > oa =) 2 4 o rs E ra rr) =) ° E 7 =< = S e = e o wi ce) ° a ana @ CERTIFICATE @ Ea Gictice Ci eo, mere LG & iti ne ge hetipreaicen ae ses oei008 EC Certificate Production Quality Assurance System tve 93/42/EEC on Medical Devices (MDD), Annex V 28 in class I in sterile conditions, sterilised systems or procedure packs) No. G2S 092387 0002 Rev. 00 Facility(ies): Suzhou Vicon Industrial Co., Ltd. NO.14, Shitian Road, Yangchenghu Town, Xiangcheng District, 218122 Suzhou, Jiangsu, PEOPLE'S REPUBLIC OF CHINA Page 2 of 2 ‘TUV SUD Product Service GmbH is Notified Body with identification no. 0123 TOV SUD Product Service GmbH + Certification Body « Ridlerstrafe 65 + 80339 Munich + Germany