国食药监械(进)字2012第3463337号(更)

Synthes GmbH

Eimattstrasse 3, 4436 Oberdorf, Switzerland

Eimattstrasse 3,4436 Oberdorf,Switzerland；Glutz Blotzheim-Str. 1 und 3,4500Solothurn, Switzerland；Bohnackerweg 5, 2545Selzach, Switzerland；Hauptstrasse 24, 4437Waldenburg, Switzerland；Luzernstrasse 19, 4500Solothurn, Switzerland；Muracherstrasse 3,2544Bettlach, Switzerland；Solothurnstrasse 186, 2540Grenchen, Switzerland; Im Bifang 6,4614 H?gendorf,Switzerland; Zona Industriale 4,6805 Mezzovico,Switzerland; Stabile Morina, 6805 Mezzovico,SwitzerlandKanalstrasse West 30, 3942 Raron,Switzerland；Dornacherstrasse 20, 4710 Balsthal,Switzerland; Im Kirchenhürstle 4-6, 79224 Umkirchb.Freiburg, Germany; Karolingerstr. 16, 5020Salzburg, Austria; 108 Willowbrook Lane, WestChester, PA 19382, USA1302 Wrights Lane East, WestChester, PA 19380, USA；1303 Goshen Parkway, WestChester, PA 19380, USA; 1301 Goshen Parkway, WestChester, PA 19380, USA; 1230 Wilson Drive, WestChester, PA 19380, USA1690 Russell Road, Paoli, PA19301, USA; 1051 Synthes Avenue, Monument, CO80132, USA; 35 Airport Road, Horseheads, NY 14845,USA; 6244 Ferris Square, Suite B, San Diego, CA92121, USA

辛迪思(上海)医疗器械贸易有限公司

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接骨螺钉 Screws

3

见附页

该产品采用符合ISO 5832-11规定的钛6铝7铌钛合金材料或符合ISO 5832-1规定的不锈钢材料制造。钛合金材料制造的接骨螺钉产品表面经阳极氧化着色处理。该产品包装分为灭菌包装和非灭菌包装两种。

该产品与SYNTHES的锁定接骨板配合用于四肢、手足及锁骨骨折断端或骨碎片的临时稳定,直到骨愈合为止。

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代理人由“辛迪思(上海)医疗器械贸易有限公司”变更为“强生(上海)医疗器材有限公司”；售后服务机构由“辛迪思(上海)医疗器械贸易有限公司”变更为“辛迪思(上海)医疗器械贸易有限公司、强生(上海)医疗器材有限公司”。注册证由“国食药监械(进)字2012第3463337号”变更为“国食药监械(进)字2012第3463337号(更)”,原证自发证之日起作废。

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2012.09.11

2016.09.10

2013.04.25变更