a 4 ry ns = co rr] o Sd o =) 3 o a = CS wi o Bd re 4 7 a a = re ce wi ce) Bd Bee id fi ZERTIFIKAT ® CERTIFICATE @ EC Certificate Production Quality Assurance System Directive 93/42/EEC on Medical Devices (MDD), Annex V (Devices in Class lla, IIb or ill) No. G2 086389 0010 Rev. 00 Manufacturer: Yangzhou Super Union Import & Export Co., Ltd. 'No.120 Xishan South Road Ghenii Town 211408 Yizheng City, Jiangsu Province PEOPLE'S REPUBLIC OF CHINA EC-Representative: Shanghai Intemational Holcing Corp. GmbH (Europe) Eiffestrate 80, 20537 Hamburg, GERMANY Disposabl Product ee Disposable Surgical Blades (with and without Handle), Category(ies): Sterle Blood Lance's, Sterile Syringes for Single Use, Sterile Infusion Sets for Single Us Sterile Transfusion Set for Single Use, ‘Sterile Scalp Vein Type Needles for Single Uso, Sterile Hypodormic Needles for Single Use, Sterile Insulin Syringes for Single Use, Disposable lrrigating and Feeding Syringes, Disposable Medical Three-way Stopcocks, Disposable Connecting Extension Tubes, Disposable infusion Enteral Giving Set, Umbilical Cord Clamp, Silicone Suction Reservoir and Flat Drain (Round Drain), Connection Cannula, Sterile Suction Tube (Yankauer Suction Set), Laryngeal Mask, Endotracheal Tube, Proformed Nasal and Oral Tracheal Tube, Reinforced Endotracheal Tube, ‘Suction Catheter, Mucus Extractor, ‘Tracheostomy Tube, Oxygen Mask, Nelaton Tubo, Silicone Foley Catheter, Nasal Oxygen Cannula, Feeding Tube, Abdominal/Thoracic Drain Tub, ‘Stomach Tube, Sterile Gauze Swabs with X-ray, ‘Sterile Lap Sponges with X-ray, Sterile Non-woven Sponges with X-ray ‘The Certification Body of TV SUD Product Service GmbH declares thatthe aforementioned manufacturer has implemented a quality assurance system for manufacture and final inspection ofthe respective devices / device categories in accordance with MDD Annex V. This quality assurance system conforms to the requirements ofthis Directive and is subject to periodical surveillance. For marketing of clas lib and Ill devices an additional Annex Il cerifcate is mandatory. See also notes overleaf. Report No.: Valid from: Valid until: Date, Page 1 of 2 ‘SH16815EXTO1 2019-04-09 2024-04-08 ee | Fron | Stefan Preit TOV SUD Product Service GmbH is Notified Body with identification no. 0123 ‘TOV SUD Product Service GmibH + Certification Body + Rlerstrae 65 + 80339 Munich » Germany= =< o = = = ry o PS o a! 4 Pr] a = = i o 1 @ aS 3 Sj = 6 Ss be es wi ° CS a cl re ZERTIFIKAT @ CERTIFICATE ° Prost Somes EC Certificate Production Quality Assurance System Directive 99/42/EEC on Medical Devices (MDD), Annex V (Devices in Class tla Ib or I) No. G2 086389 0010 Rev. 00 Facility(ies): Yangzhou Super Union Import & Export Co., Ltd. No.120 Xishan South Road, Chenji Town, 211408 Yizheng City, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA Page 2 of 2 ‘TUV SUD Product Service GmbH is Notified Body with identification no. 0123 TUV SUD Product Service GmbH + Certification Body + Ridlerstrale 65 » 80339 Munich - Germany