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2019年3月【國(guó)家食藥監(jiān)局】進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息目錄

發(fā)布時(shí)間：2019-04-04 15:20:24 來源：國(guó)家藥品監(jiān)督管理局網(wǎng)站 作者：admin

2019年3月【國(guó)家食藥監(jiān)局】進(jìn)口***類醫(yī)療器械產(chǎn)品備案信息目錄

2019年3月進(jìn)口***類醫(yī)療器械產(chǎn)品備案信息（武漢克瑞普新技術(shù)有限公司-東科圣康牌骨科高分子夾板、肋骨固定板、醫(yī)用外固定支具、醫(yī)用固定帶生產(chǎn)廠家轉(zhuǎn)載編輯）。詳見下表：

2019年3月進(jìn)口***類醫(yī)療器械產(chǎn)品備案信息
序號(hào) 產(chǎn)品名稱 備案號(hào) 備案人名稱原文 生產(chǎn)地址原文 備案日期 狀態(tài)
1 牙科種植工具  國(guó)械備20160057號(hào) MOZO GRAU, S.A. C/Santiago Lopez Gonzalez, 7, 47197, VALLADOLID, Spain 2019-03-29 變更
2 牽開器 國(guó)械備20190330號(hào) ZEPF MEDICAL INSTRUMENTS GMBH Gunningerstraβe. 21, 78606 SEITINGEN-OBERFLACHT, Germany 2019-03-28 ***
3 手術(shù)鉤 國(guó)械備20190329號(hào) ZEPF MEDICAL INSTRUMENTS GMBH Gunningerstraβe. 21, 78606 SEITINGEN-OBERFLACHT, Germany 2019-03-28 ***
4 下肢固定器 國(guó)械備20190328號(hào) THUASNE SAS 4615 Shepard St. Bakersfield , CA 93313 2019-03-28 ***
5 牙科工具 國(guó)械備20190327號(hào) MOZO-GRAU, S.A. C/Santiago López González, 7, 47197 Valladolid. Spain 2019-03-28 ***
6 牙科用剪 國(guó)械備20190326號(hào) Bizztrex International Rchna Centre, Razi ENT, Commissioner Road, Sialkot - Pakistan 2019-03-27 ***
7 檢查手套 國(guó)械備20171007號(hào) SEMPERIT INVESTMENTS ASIA PTE LTD LOT 10558, JALAN PERUSAHAAN 3,KAMUNTING INDUSTRIAL ESTATE 34600 KAMUNTING, TAIPING, PERAK, MALAYSIA 2019-03-26 變更
8 檢查手套 國(guó)械備20171006號(hào) SEMPERIT INVESTMENTS ASIA PTE LTD LOT 10558, JALAN PERUSAHAAN 3,KAMUNTING INDUSTRIAL ESTATE 34600 KAMUNTING, TAIPING, PERAK, MALAYSIA 2019-03-26 變更
9 醫(yī)用座墊 國(guó)械備20190325號(hào) Sunrise Medical (US) LLC 2842 Business Park Avenue Fresno, CA USA 93727 2019-03-26 ***
10 緩沖液 國(guó)械備20190324號(hào) Agilent Technologies,Inc. 1834 State Highway71 West, Cedar Creek, TX, 78612,  United States 2019-03-26 ***
11 醫(yī)用橡膠手套 國(guó)械備20190323號(hào) SUPERMAX GLOVE MANUFACTURING SDN.BHD. LOT 38,PUTRA INDUSTRIAL PARK,BUKIT RAHMAN PUTRA,47000 SUNGAI BULOH,SELANGOR DARUL EHSAN,MALAYSIA. 2019-03-26 ***
12 擔(dān)架 國(guó)械備20190322號(hào) EGO Zlín, spol. s r.o. U Pekárny 438, Štípa, 763 14 Zlín, Czech Republic 2019-03-26 ***
13 牙科潔治器 國(guó)械備20190321號(hào) Bizztrex International Rchna Centre, Razi ENT, Commissioner Road, Sialkot - Pakistan 2019-03-26 ***
14 拔牙鉗 國(guó)械備20190320號(hào) Bizztrex International Rchna Centre, Razi ENT, Commissioner Road, Sialkot - Pakistan 2019-03-26 ***
15 牙科用鑷 國(guó)械備20190319號(hào) Bizztrex International Rchna Centre, Razi ENT, Commissioner Road, Sialkot - Pakistan 2019-03-26 ***
16 牙挺 國(guó)械備20190318號(hào) Bizztrex International Rchna Centre, Razi ENT, Commissioner Road, Sialkot - Pakistan 2019-03-26 ***
17 骨測(cè)量器 國(guó)械備20150899號(hào) Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653,USA 2019-03-25 變更
18 骨科撐開器 國(guó)械備20150911號(hào) Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653,USA 2019-03-25 變更
19 髕骨鉗 國(guó)械備20150905號(hào) Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653,USA 2019-03-25 變更
20 股骨髓腔探棒 國(guó)械備20150883號(hào) Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653,USA 2019-03-25 變更
21 IgM抗體試劑（免疫組織化學(xué)） 國(guó)械備20190317號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-25 ***
22 Tyrosinase抗體試劑（免疫組織化學(xué)） 國(guó)械備20190316號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-25 ***
23 骨科定位片 國(guó)械備20150912號(hào) Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653,USA 2019-03-25 變更
24 骨鑿 國(guó)械備20150898號(hào) Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653,USA 2019-03-25 變更
25 牙科器械鉗 國(guó)械備20190315號(hào) Bizztrex International Rchna Centre, Razi ENT, Commissioner Road, Sialkot - Pakistan 2019-03-25 ***
26 膝關(guān)節(jié)手術(shù)導(dǎo)板 國(guó)械備20190314號(hào) 愛派司生技股份有限公司 新北市中和區(qū)橋和路120號(hào)2樓之2 2019-03-25 ***
27 脊柱后路內(nèi)固定系統(tǒng)手術(shù)工具 國(guó)械備20190313號(hào) bricon GmbH Villigerstrasse 33 78166 Donaueschingen Germany 2019-03-25 ***
28 造口袋 國(guó)械備20190312號(hào) Hollister Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA 2019-03-25 ***
29 造口底盤 國(guó)械備20190311號(hào) Hollister Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA 2019-03-25 ***
30 快裝手柄 國(guó)械備20150906號(hào) Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653,USA 2019-03-25 變更
31 骨科鉆孔瞄準(zhǔn)器 國(guó)械備20150885號(hào) Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653,USA 2019-03-25 變更
32 骨科用螺絲刀 國(guó)械備20150896號(hào) Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653,USA 2019-03-25 變更
33 骨錘 國(guó)械備20150875號(hào) Exactech,Inc. 2320 NW 66th,Court Gainesville,Florida 32653,USA 2019-03-25 變更
34 骨銼 國(guó)械備20150908號(hào) Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653,USA 2019-03-25 變更
35 骨撬 國(guó)械備20150909號(hào) Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653,USA 2019-03-25 變更
36 截骨刀 國(guó)械備20150910號(hào) Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653,USA 2019-03-25 變更
37 Lysozyme抗體試劑（免疫組織化學(xué)） 國(guó)械備20190310號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-22 ***
38 CD61抗體試劑（免疫組織化學(xué)） 國(guó)械備20190309號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-22 ***
39 骨刮匙 國(guó)械備20150522號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
40 骨膜剝離器 國(guó)械備20150524號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
41 骨科撐開器 國(guó)械備20150792號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
42 試模 國(guó)械備20150699號(hào) Aesculap AG Am Aesculap-platz, 78532 Tuttlingen, Germany 2019-03-22 變更
43 骨科用螺絲刀 國(guó)械備20150539號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
44 手術(shù)拉鉤 國(guó)械備20150077號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
45 CD57抗體試劑（免疫組織化學(xué)） 國(guó)械備20190308號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-22 ***
46 IgD抗體試劑（免疫組織化學(xué)） 國(guó)械備20190307號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-22 ***
47 細(xì)胞角蛋白17抗體試劑（免疫組織化學(xué)） 國(guó)械備20190306號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-22 ***
48 EMA抗體試劑（免疫組織化學(xué)） 國(guó)械備20190305號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-22 ***
49 跗骨手術(shù)工具 國(guó)械備20190168號(hào) GraMedica 16137 Leone Drive, Macomb, MI, 48042, United States 2019-03-22 變更
50 器械鉗 國(guó)械備20150889號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
51 壓腸板 國(guó)械備20150890號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
52 下肢截?cái)嗬^ 國(guó)械備20151088號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
53 拉鉤裝置器 國(guó)械備20151089號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
54 鋼絲鉗 國(guó)械備20151090號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
55 骨膜剝離器 國(guó)械備20150507號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
56 低離子強(qiáng)度鹽溶液 國(guó)械備20151461號(hào) Immucor, Inc.  3130 Gateway Drive, Norcross, Georgia 30071, USA 2019-03-22 變更
57 頭戴式放大鏡 國(guó)械備20140236號(hào) Metrex Research LLC dba Orascoptic 3225 Deming Way Suite 190 Middleton, WI 53562 2019-03-21 變更
58 頭戴式檢查燈 國(guó)械備20181596號(hào) Metrex Research LLC dba Orascoptic 3225 Deming Way Suite 190 Middleton,WI USA 53562 2019-03-21 變更
59 頭戴式檢查燈 國(guó)械備20181247號(hào) Metrex Research LLC dba Orascoptic 3225 Deming Way Suite 190 Middleton,WI USA 53562 2019-03-21 變更
60 醫(yī)用光學(xué)放大鏡 國(guó)械備20190118號(hào) Metrex Research LLC dba Orascoptic 3225 Deming Way Suite 190 Middleton,WI USA 53562 2019-03-21 變更
61 頭戴式放大鏡 國(guó)械備20140247號(hào) Metrex Research LLC dba Orascoptic 3225 Deming Way Suite 190 Middleton, WI 53562 2019-03-21 變更
62 牙科分離劑 國(guó)械備20190304號(hào) DENTSPLY International, Inc. Dentsply Ceramco 570 West College Avenue York Pennsylvania 17401 USA 2019-03-21 ***
63 種植用手術(shù)導(dǎo)板 國(guó)械備20181390號(hào) 3D Systems Inc. Route de l'Ancienne Papeterie, 1723 Marly, Switzerland 2019-03-21 變更
64 口腔麻醉劑手動(dòng)助推器 國(guó)械備20190303號(hào) Bizztrex International Rchna Centre, Razi ENT, Commissioner Road, Sialkot - Pakistan 2019-03-21 ***
65 咬骨鉗 國(guó)械備20150312號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-21 變更
66 防漏膏 國(guó)械備20190302號(hào) B. Braun Hospicare Ltd 2055 Luna Road, #126, Carrollton Texas 75006 USA 2019-03-21 ***
67 外科牽開器 國(guó)械備20151219號(hào) Thompson Surgical Instruments, Inc. 10170 East Cherry Bend RD., Traverse City, MI USA 49684 2019-03-21 變更
68 轉(zhuǎn)移帽 國(guó)械備20180560號(hào) Alpha-Bio Tec Ltd. 7 Hatnufa St.,Kiryat Arye,POB 3936 Petach Tikva,4951025,Israel 2019-03-21 變更
69 替代體 國(guó)械備20190301號(hào) Zest Anchors, LLC 2875 Loker Avenue East Carlsbad California 92010 USA;2230 Enterprise Street Escondido California 92029 USA 2019-03-21 ***
70 螺絲起 國(guó)械備20190300號(hào) Zest Anchors, LLC 2875 Loker Avenue East Carlsbad California 92010 USA;2230 Enterprise Street Escondido California 92029 USA 2019-03-21 ***
71 全自動(dòng)樣品處理系統(tǒng) 國(guó)械備20150222號(hào) Siemens Healthcare Diagnostics Inc. Via Givoletto 15, I-10040, VAL DELLA TORRE (TO) 2019-03-20 變更
72 牙科種植專用器械包 國(guó)械備20161332號(hào) DIO Corporation 66, Centumseo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA 2019-03-19 變更
73 醫(yī)用檢查手套 國(guó)械備20190299號(hào) A R MEDICOM (M) SDN BHD 3RD FLOOR, WISMA KOON HOE, NO.3 JALAN 13/3, 46200 PETALING JAYA, SELANGOR DARUL EHSAN, MALAYSIA 2019-03-19 ***
74 骨粉調(diào)和用金屬容器 國(guó)械備20190298號(hào) (?)????? 57, Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do 2019-03-19 ***
75 骨科用螺絲刀 國(guó)械備20150877號(hào) SCIENT'X SAS 22 rue Jean Bart 78960 VOISINS LE BRETONNEUX FRANCE 2019-03-19 變更
76 壓縮鉗 國(guó)械備20140349號(hào) SCIENT'X SAS 22 rue Jean Bart 78960 VOISINS LE BRETONNEUX FRANCE 2019-03-19 變更
77 骨科復(fù)位鉗 國(guó)械備20140348號(hào) SCIENT'X SAS 22 rue Jean Bart 78960 VOISINS LE BRETONNEUX FRANCE 2019-03-19 變更
78 扳手 國(guó)械備20140350號(hào) SCIENT’X SAS 22 rue Jean Bart 78960 VOISINS LE BRETONNEUX FRANCE 2019-03-19 變更
79 冷敷凝膠 國(guó)械備20190297號(hào) 威尼斯藥廠有限公司 桃園市蘆竹區(qū)外社里草仔崎路88號(hào) 2019-03-18 ***
80 牙科加壓器 國(guó)械備20190296號(hào) DIADENT GROUP INTERNATIONAL 16, Osongsaengmyeong 4-ro Osong-eup Heungdeok-gu ,Cheongju-si Chungcheongbuk-do，28161 Republic of Korea 2019-03-18 ***
81 阿利辛藍(lán)﹣過碘酸雪夫氏染色液 國(guó)械備20161937號(hào) Leica Biosystems Richmond, Inc. 5205 Route 12,P.O.Box 528 Richmond, Illinois 60071,USA 2019-03-18 變更
82 過碘酸雪夫染色液 國(guó)械備20161940號(hào) Leica Biosystems Richmond, Inc. 5205 Route 12,P.O.Box 528 Richmond, Illinois 60071,USA 2019-03-18 變更
83 抗體稀釋液 國(guó)械備20190083號(hào) Dako North America, Inc. 1170 Mark Ave. Carpinteria, CA 93013 United States 2019-03-18 變更
84 ALK抗體試劑（免疫組織化學(xué)） 國(guó)械備20190295號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-15 ***
85 HMB-45抗體試劑（免疫組織化學(xué)） 國(guó)械備20190294號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-15 ***
86 CD45RO抗體試劑（免疫組織化學(xué)） 國(guó)械備20190293號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-15 ***
87 CD45抗體試劑（免疫組織化學(xué)） 國(guó)械備20190292號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-15 ***
88 bcl-2抗體試劑（免疫組織化學(xué)） 國(guó)械備20190291號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-15 ***
89 CD8抗體試劑（免疫組織化學(xué)） 國(guó)械備20190290號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-15 ***
90 CD2抗體試劑（免疫組織化學(xué)） 國(guó)械備20190289號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-15 ***
91 CD68抗體試劑（免疫組織化學(xué)） 國(guó)械備20190288號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-15 ***
92 CD25抗體試劑（免疫組織化學(xué)） 國(guó)械備20190287號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-15 ***
93 橡皮障 國(guó)械備20190286號(hào) 艾瑞瓷精密股份有限公司 臺(tái)灣新北市土城區(qū)自強(qiáng)街5號(hào)1、2樓及7號(hào)1、2樓(實(shí)際醫(yī)療器材生產(chǎn)區(qū)域?yàn)?號(hào)1樓及7號(hào)2樓) 2019-03-15 ***
94 造口袋 國(guó)械備20181618號(hào) Hollister Incorporated 366 Draft Ave STUARTS DRAFT,VA USA 24477 2019-03-14 變更
95 指骨夾板 國(guó)械備20161631號(hào) healthnuri 18, Geumamdongseok 1-gil, Dongmyeong-myeon, Chilgok-gun, Gyeongsangbuk-do 2019-03-14 變更
96 創(chuàng)口貼 國(guó)械備20170736號(hào) ?????????(?) ??? ??? ??? ??? 70-17 2019-03-14 變更
97 骨科外固定夾板 國(guó)械備20190285號(hào) THUASNE DEUTSCHLAND GmbH Im Steinkamp 12, 30938 Burgwedel 2019-03-14 ***
98 CD30抗體試劑（免疫組織化學(xué)） 國(guó)械備20190284號(hào) Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. 2019-03-14 ***
99 醫(yī)用射線防護(hù)用具 國(guó)械備20190283號(hào) PROTECH LEADED EYEWEAR,INC. 1360 N Killian Dr Ste2 Lake Park,FL 33403 2019-03-14 ***
100 聚酯襯墊 國(guó)械備20151171號(hào) BL TECH CO.,LTD. 84,Toegyenonggong-ro, Chuncheon-si, Gangwon-do, Korea 2019-03-13 變更
101 牙科拋光磨頭 國(guó)械備20190282號(hào) Kenda AG Kanalstrasse 18， 9490 Vaduz, Liechtenstein 2019-03-13 ***
102 液基薄層細(xì)胞制片機(jī) 國(guó)械備20190281號(hào) （?）??????? ?? ??? ??? ??? ??? 228?? 15, 3? 3?(???,????????1) 2019-03-12 ***
103 清洗液 國(guó)械備20160467號(hào) Ortho Clinical Diagnostics 100 Indigo Creek Drive, Rochester, New York, 14626 USA;

Second Avenue, Heather House Industrial Estate, Irvine, Ayrshire, Scotland, KA12 8NB, United Kingdom		 2019-03-12 變更
104 硅橡膠復(fù)制材料 國(guó)械備20190280號(hào) ?? ????? ??? ??? 224 1,2.3?(???) 2019-03-12 ***
105 牙科磷酸鹽鑄造包埋材 國(guó)械備20190279號(hào) ?? ????? ??? ??? 224 1,2.3?(???) 2019-03-12 ***
106 醫(yī)用檢查手套 國(guó)械備20190278號(hào) HARTALEGA SDN. BHD. No.7, Kawasan Perusahaan Suria, Bestari Jaya, 45600 Selangor Darul Ehsan,MALAYSIA 2019-03-12 ***
107 全自動(dòng)核酸提取純化儀 國(guó)械備20160221號(hào) Tecan Schweiz AG Seestraβe 103, CH-8708 Mannedorf, Switzerland 2019-03-12 變更
108 頭戴式檢查燈 國(guó)械備20190277號(hào) 永島醫(yī)科器械株式會(huì)社 東京都文京區(qū)本郷4－1－12 2019-03-12 ***
109 醫(yī)用鑷 國(guó)械備20170077號(hào) Teleflex  Medical 2917 Weck Drive, Research Triangle Park, NC 27709, USA 2019-03-11 變更
110 縫隙封閉糊劑 國(guó)械備20190276號(hào)  Ultradent Products, Inc. 505 West Ultradent Drive (10200 South), South Jordan, Utah 84095, USA 2019-03-11 ***
111 手動(dòng)推床 國(guó)械備20190275號(hào) Stryker Medical 3800 E. Centre Avenue Portage Michigan 49002 USA 2019-03-11 ***
112 人體定位袋 國(guó)械備 20150038號(hào) Qfix 440 Church Road Avondale,PA 19311 2019-03-08 變更
113 緩沖液 國(guó)械備20190274號(hào) Roche Diagnostics GmbH Sandhofer Strasse 116,68305 Mannheim,Germany 2019-03-08 ***
114 緩沖液 國(guó)械備20190273號(hào) Roche Diagnostics GmbH Sandhofer Strasse 116,68305 Mannheim,Germany 2019-03-08 ***
115 救護(hù)車擔(dān)架 國(guó)械備20151325號(hào) ME.BER S.r.l. Unipersonale Via Langhirano, 270 l-43124 FONTANINI (PR) 2019-03-08 變更
116 電動(dòng)移位機(jī) 國(guó)械備20190272號(hào) Liko AB Nedre Vägen 100, SE-975 92 Luleå, Sweden 2019-03-07 ***
117 口外研磨材料 國(guó)械備20190271號(hào) 株式會(huì)社ジーシーデンタルプロダクツ 愛知県春日井市勝川町１丁目３－３ 2019-03-06 ***
118 bcl-2抗體試劑（免疫組織化學(xué)） 國(guó)械備20190270號(hào) Bio SB, Inc. 69 Santa Felicia Drive., Santa Barbara, California 93117, USA 2019-03-06 ***
119 骨髓增生異常綜合征染色體及基因異常檢測(cè)試劑盒（原位雜交法） 國(guó)械備20190269號(hào) ZytoVision GmbH Fischkai 1 27572 Bremerhaven Germany 2019-03-06 ***
120 藥粉吸入器 國(guó)械備20190268號(hào) Novartis Pharma Stein AG Schaffhauserstrasse CH-4332 Stein, Switzerland 2019-03-06 ***
121 足踝釘板系統(tǒng)手術(shù)器械包 國(guó)械備20190267號(hào) Wright Medical Technology, Inc 11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA 2019-03-05 ***
122 替代體 國(guó)械備20190265號(hào) 全球安聯(lián)科技股份有限公司 南科高雄園區(qū)高雄市路竹區(qū)路科五路92號(hào)2樓、96號(hào)2樓 2019-03-05 ***
123 防漏膏 國(guó)械備20190264號(hào) ConvaTec Inc. Carretera Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic. 2019-03-05 ***
124 牙刮匙 國(guó)械備20152098號(hào) Kohdent Roland Kohler Medizintechnik GmbH & Co.KG Bodenseeallee 14-16 78333 Stockach Germany 2019-03-05 變更
125 耳鼻喉科手術(shù)器械 國(guó)械備20190263號(hào) PANORAMA INTERNATIONAL Defence Road,Near China Chowk,Gulshan lqbal Park,Sialkot-51310-Pakistan. 2019-03-05 ***
126 牙科拋光器 國(guó)械備20190262號(hào) Ultradent Products, Inc. Kanalstrasse 18,9490 Vaduz, Liechtenstein 2019-03-04 ***
127 螺絲起 國(guó)械備20151268號(hào) Thommen Medical AG Neckarsulmstrasse 28, 2540 Grenchen, Switzerland 2019-03-04 變更
128 螺絲起 國(guó)械備20161552號(hào) Medentis medical GmbH Walporzheimer Str. 48-52 53474 Bad Neuenahr-Ahrweiler Deutschland 2019-03-04 變更
129 脊柱用手術(shù)工具 國(guó)械備20181233號(hào) Medtronic Sofamor Danek USA, Inc. 4340 Swinnea Road, Memphis, TN 38118, USA 2019-03-04 變更
130 鏟式擔(dān)架 國(guó)械備20151329號(hào) ME.BER S.r.l. Unipersonale Via Langhirano, 270 l-43124 FONTANINI (PR) 2019-03-04 變更
131 擔(dān)架 國(guó)械備20151328號(hào) ME.BER S.r.l. Unipersonale Via Langhirano, 270 l-43124 FONTANINI (PR) 2019-03-04 變更
132 替代體 國(guó)械備20190261號(hào) SIC invent AG Im Rott 5-10, 69493 Hirschberg Germany; Josef-Beyerle-Straße 14, 71263 Weil der Stadt, Germany; 2875 Loker Avenue East, Carlsbad, California 92010, USA; Champs-Montants 16a, 2074 Marin-Epagnier, Switzerland 2019-03-04 ***
133 醫(yī)用轉(zhuǎn)運(yùn)車 國(guó)械備20190260號(hào) Wardray Premise Limited Unit 2 - Springvale Works, Elland Road, Brighouse, West Yorkshire, HD6 2RN,UK 2019-03-04 ***
134 全自動(dòng)樣品處理系統(tǒng) 國(guó)械備20190259號(hào) PerkinElmer,Inc. 68 Elm Street, Hopkinton, MA 01748, USA 2019-03-01 ***
135 口腔科手術(shù)器械 國(guó)械備20190258號(hào) SUSTAINABLE INSTRUMENTS 8-A,Allama Iqbal Road Small Industrial Estate,P.O.Box 1637,Sialkot-Pakistan 2019-03-01 ***
136 基礎(chǔ)外科手術(shù)器械 國(guó)械備20190257號(hào) SUSTAINABLE INSTRUMENTS 8-A,Allama Iqbal Road Small Industrial Estate,P.O.Box 1637,Sialkot-Pakistan 2019-03-01 ***
137 醫(yī)用干式膠片 國(guó)械備20170743號(hào) AGFA HEALTHCARE N.V. Septestraat 27, 2640 Mortsel, Belgium; 1658 Bushy Park Road, Goose Creek, South Carolina 29445, USA 2019-03-26 變更
138 咬骨鉗 國(guó)械備20161033號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-25 變更
139 扳手 國(guó)械備20160982號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-25 變更
140 骨錘 國(guó)械備20160758號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-25 變更
141 組織拉鉤 國(guó)械備20161689號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-25 變更
142 弓鋸 國(guó)械備20161845號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-25 變更
143 子宮刮匙 國(guó)械備20161832號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-25 變更
144 鼻刮匙 國(guó)械備20161844號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-25 變更
145 會(huì)陰牽開器 國(guó)械備20161830號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-25 變更
146 顯微剝離器 國(guó)械備20161695號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-25 變更
147 耳息肉圈斷器 國(guó)械備20161693號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-25 變更
148 扁桃體刀 國(guó)械備20160755號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
149 顱骨鉆 國(guó)械備20170962號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
150 全自動(dòng)核酸提取儀 國(guó)械備20161389號(hào) Thermo Fisher Scientific Oy Ratastie 2, 01620 Vantaa Finland 2019-03-22 無效
151 全自動(dòng)核酸提取儀 國(guó)械備20161388號(hào) Thermo Fisher Scientific Oy Ratastie 2, 01620 Vantaa Finland 2019-03-22 無效
152 全自動(dòng)核酸提取儀 國(guó)械備20161387號(hào) Thermo Fisher Scientific Oy Ratastie 2, 01620 Vantaa Finland 2019-03-22 無效
153 全自動(dòng)核酸提取儀 國(guó)械備20160204號(hào) Thermo Fisher Scientific Oy Ratastie 2, 01620 Vantaa, Finland 2019-03-22 無效
154 膽石匙 國(guó)械備20160957號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
155 石膏撐開器 國(guó)械備20161876號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
156 眼科鉗 國(guó)械備20170455號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
157 腦壓板 國(guó)械備20171013號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
158 牙挺 國(guó)械備20171149號(hào) Aesculap AG Am Aesculap-Platz, 78532 Tuttlingen, Germany 2019-03-22 變更
159 頭戴式放大鏡 國(guó)械備20162018號(hào) Metrex Research LLC dba Orascoptic 3225 Deming Way Suite 190 Middleton Wisconsin 53562 USA 2019-03-21 變更
160 上頜竇提升器 國(guó)械備20170772號(hào) MegaGen Implant Co.,Ltd. 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si, Gyeongsangbuk-do, Korea 2019-03-19 變更
161 鉆針深度停止器 國(guó)械備20170905號(hào) MegaGen Implant Co.,Ltd. MEGAGEN Implant, 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si, Gyeongsangbuk-do, Korea 2019-03-19 變更
162 壓力繃帶 國(guó)械備20180182號(hào) CIZETA MEDICALI S.P.A. Via IV Novembre,46-20012 CUGGIONO(MI)-ITALY 2019-03-18 變更
163 骨科手術(shù)工具包 國(guó)械備20170301號(hào) Bioplate, Inc. 3643 Lenawee Avenue, Los Angeles, California 90016, USA 2019-03-13 變更
164 髖關(guān)節(jié)手術(shù)器械 國(guó)械備20151787號(hào) Smith & Nephew,Inc. 見附件 2019-03-12 變更
165 膝關(guān)節(jié)手術(shù)器械 國(guó)械備20140291號(hào) Smith & Nephew,Inc. 1450 Brooks Road Memphis Tennessee 38116 USA; 

2 Lengkok Teluk Kumbar 1 Jalan Teluk Kumbar 11920 Bayan Lepas, Penang Malaysia		 2019-03-12 變更
166 手持式眼瞼張開器 國(guó)械備20180655號(hào) TearScience,Inc 5151 McCrimmon Parkway Suite 250 Morrisville North Carolina 27560 USA 2019-03-07 變更
167 種植體掃描體 國(guó)械備20170627號(hào) Osstem Implant Co.,Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea 2019-03-06 變更
168 內(nèi)提升工具盒 國(guó)械備20161757號(hào) Osstem Implant Co.,Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea 2019-03-06 變更
169 醫(yī)用外固定四肢及關(guān)節(jié)支具 國(guó)械備20160885號(hào) 彪仕醫(yī)技股份有限公司 臺(tái)南市南區(qū)中華西路一段23號(hào) 2019-03-05 變更
170 醫(yī)用外固定軀干支具 國(guó)械備20160884號(hào) 彪仕醫(yī)技股份有限公司 臺(tái)南市南區(qū)中華西路一段23號(hào) 2019-03-05 變更
171 深呼吸訓(xùn)練器 國(guó)械備20171222號(hào) Teleflex Medical Ave. Industrias No 5954, Parque Industrial Finsa, Nuevo Laredo,Tamaulipas, 88275, Mexico; Prolongacion Mision Eusebio Kino No. 1316,Rancho El Descanso, Tecate B.C., C.P. 21478, Mexico 2019-03-01 變更
172 輸氧面罩 國(guó)械備20161297號(hào) Teleflex Medical  AVE. INDUSTRIAS NO 5954，PARQUE INDUSTRIAL FINSA, NUEVO LAREDO, TAMAULIPAS Mexico 88275 2019-03-01 變更

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