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2022年8月進口第一類醫療器械產品備案信息
作者：admin     時間：2022-09-11 14:50:37
63.8K

 發布時間：2022-09-08


序號產品名稱備案號備案人名稱原文生產地址原文備案日期狀態
1器械鉗國械備20171065號Boston   Scientific Corporation10700   Bren Road West, Minnetonka, MN USA 553432022-08-31 變更
2導引針國械備20171015號Boston   Scientific Corporation10700   Bren Road West, Minnetonka, MN USA 553432022-08-31 變更
3機用螺絲刀國械備20170338號DENTSPLY   Implants Manufacturing GmbHAminogatan   1, PO Box 14, 43121 M?lndal,SWEDEN2022-08-31 變更
4全自動樣品處理系統國械備20220379號Inpeco   S.A.Via   Givoletto 15 I-10040, Val della Torre (TO), Italy2022-08-31 有效
5測瓣器組件國械備20210477號Corcym   S.r.l.Via   Crescentino sn, 13040 Saluggia (VC) ITALY2022-08-31 變更
6口腔燈國械備20150446號G.   COMM S.r. l.VIA   DONIZETTI 22 I-20872 CORNATE D’ADDA(MB)2022-08-31 變更
7口腔燈國械備20151258號G.   COMM S.r. l.VIA   DONIZETTI 22 I-20872 CORNATE D’ADDA(MB)2022-08-31 變更
8乳牙充填成形冠套國械備20220034號Shinhung   Co., Ltd.42-25,   Dongsan-ro 27beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, 15433, Korea2022-08-31 變更
9上頜竇內提升器國械備20190248號SAWUAT   SURGICALQadoos   Street Kacha Shahab Pura, Small Industrial Area, Sialkot - Pakistan2022-08-31 變更
10牙科種植手術取模工具包國械備20170506號Thommen   Medical AGNeckarsulmstrasse   28,2540 Grenchen Switzerland2022-08-30 變更
11醫用檢查手套國械備20161050號N.S.UNI-GLOVES   SDN.BHD.Lot   3&4/4510 Lorong Senawang 4/1, Senawang Industrial Estate, 70450 Seremban   Negeri Sembilan Darul Khusus2022-08-30 變更
12矯形外科手術器械國械備20170300號MEDESY   SRLVIALE   DELL’INDUSTRIA 1-ZONA INDUSTRIALE-33085 MANIAGO(PN)2022-08-30 變更
13基礎外科手術器械國械備20170289號MEDESY   SRLVIALE   DELL’INDUSTRIA 1-ZONA INDUSTRIALE-33085 MANIAGO(PN)2022-08-30 變更
14口腔科手術器械國械備20170304號MEDESY   SRLVIALE   DELL’INDUSTRIA 1-ZONA INDUSTRIALE-33085 MANIAGO(PN)2022-08-30 變更
15集尿袋國械備20161090號Flexicare   Medical LtdCynon   Valley Business Park, Mountain Ash, Mid Glamorgan, CF45 4ER UK2022-08-30 變更
16二氧化碳吸收劑（堿石灰）國械備20151901號Flexicare   Medical LtdParkway,   Harlow Business Park, Harlow, Essex CM19 5FR, UK2022-08-30 變更
17二氧化碳吸收劑（鈣石灰）國械備20171089號Flexicare   Medical Ltd Parkway Harlow Business Park Harlow CM19 5FR   United Kingdom2022-08-30 變更
18二氧化碳吸收劑（鈉石灰）國械備20160432號Flexicare   Medical LtdParkway   Harlow Business Park Harlow CM19 5FR United Kingdom2022-08-30 變更
19引流袋國械備20170603號Serres   OyKeskustie   23, 61850 Kauhajoki As Finland2022-08-29 變更
20引流袋系統國械備20210410號Serres   OyKeskustie   23, FI-61850 Kauhajoki as, Finland2022-08-29 變更
21CEA抗體試劑（免疫組織化學）國械備20220378號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin CA 95677 USA2022-08-29 有效
22CD56   抗體試劑（免疫組織化學）國械備20220377號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin CA 95677 USA2022-08-29 有效
23全自動免疫組化獨立控溫單獨滴染染色機國械備20220376號Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA2022-08-29 有效
24醫用干式激光膠片國械備20210211號Agfa   NVSeptestraat   27, 2640 Mortsel, Belgium; 1658 Bushy Park Road, Goose Creek, South Carolina   29445, USA2022-08-29 無效
25醫用干式激光膠片國械備20210212號 Agfa NV Septestraat   27, 2640 Mortsel, Belgium; 1658 Bushy Park Road, Goose Creek, South Carolina   29445, USA2022-08-29 無效
26脊柱手術器械包國械備20171186號冠亞生技股份有限公司臺北市內湖區洲子街50號2022-08-29 變更
27耳鼻喉科手術器械包國械備20200361號Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany2022-08-29 變更
28成形片國械備20220375號Dental   Art Innovations Pty Ltd1385   Decision Street, Vista, CA 92081 USA2022-08-29 有效
29止血夾國械備20220374號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-26 有效
30椎板咬骨鉗國械備20220373號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-26 有效
31牙科種植專用器械包國械備20161332號DIO   Corporation66,   Centum seo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA2022-08-26 變更
32種植體掃描體國械備20161179號DIO   Corporation66,   Centumseo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA2022-08-26 變更
33轉移帽國械備20161140號DIO   Corporation66,   Centumseo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA2022-08-26 變更
34抗交叉反應性糖類決定簇（CCD）抗體吸附劑國械備20190588號EUROIMMUN   Medizinische Labordiagnostika AGSeekamp   31, D-23560 Lübeck, Germany2022-08-26 變更
35引流袋國械備20151343號Serres   OyKeskustie   23, 61850 Kauhajoki as Finland；Rentontie 3, Ovi H, 43100 Saarij?rvi Finland2022-08-26 變更
36牙科成形片套裝國械備20220372號Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-25 有效
37牙科用鑷國械備20220371號Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-25 有效
38膝關節手術工具國械備20210189號DePuy   Ireland UC請見附件“生產地址”。2022-08-25 變更
39腕關節固定器國械備20210578號3M   Company3M   EDUMEX, S.A DE C.V 6620 ORIENTE CALLE RAMON RIVERA LARA CD. JUAREZ,   Chihuahua, MEXICO 326052022-08-25 變更
40頸部固定器國械備20200428號3M   Company3M   Edumex S.A. de C.V.6620 Oriente Calle Ramon Rivera Lara Cd. Juarez,   Chihuahua, Mexico 32605 2022-08-25 變更
41腹部固定器國械備20200569號3M   Company 3M Edumex S.A. de C.V.6620 Oriente Calle   Ramon Rivera Lara Cd. Juarez, Chihuahua, Mexico 32605  2022-08-25 變更
42牙科成形片套裝國械備20220370號Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-25 有效
43生物顯微鏡國械備20220341號Carl   Zeiss Microscopy GmbHKǒnigsallee   9-21, 37081 Gǒttingen, Germany2022-08-25 變更
44生物顯微鏡國械備20220330號Carl   Zeiss Microscopy GmbHKǒnigsallee   9-21, 37081 Gǒttingen, Germany2022-08-25 變更
45一次性使用口腔沖洗器國械備20150611號Intersurgical   LtdCrane   House, Molly Millars Lane, Wokingham, Berkshire, RG41 2RZ, UK2022-08-25 變更
46防褥瘡床墊國械備20150035號HERNIAMESH   SRLIT-10034   CHIVASSO(TO)-VIA FRATELLI MELIGA,I/C2022-08-25 變更
47導引針國械備20170718號HERNIAMESH   SRLIT-10034   CHIVASSO(TO)-VIA FRATELLI MELIGA,1/C 2022-08-25 變更
48骨科牽引架20210276號Stryker   Endoscopy見附件2022-08-25 變更
49醫用光學生物顯微鏡國械備20220027號 Leica Microsystems CMS GmbHErnst-Leitz-Stra?e   17-37,35578 Wetzlar, GERMANY2022-08-25 變更
50自粘性硅膠膠帶國械備20220369號Paul   Hartmann AGP.I.   Pla d'en Boet II, c/Carrasco i Formiguera, 48, 08302 Mataró (Barcelona),   SPAIN2022-08-24 有效
51醫用檢查手套國械備20160956號PT.   UNIVERSAL GLOVESJI.   Pertahanan No17 Patumbak,Patumbak Deli Serdang Sumatera Utara, Indonesia2022-08-24 變更
52種植體安裝輔助器械國械備20220004號Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2022-08-23 變更
53成形片夾國械備20220367號Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-23 有效
54橡皮障國械備20220365號Elastomade   Accessories Sdn. Bhd.Lot   7, Lengkungan Hishamuddin, Perusahaan Selat Klang Utara, 42000 Port Klang,   Selangor Darul Ehsan, Malaysia2022-08-23 有效
55牙科成形片套裝國械備20220364號Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-23 有效
56給藥指套國械備20220363號H.Dam   K?rgaard A/SBorupvang   9，2750 Ballerup，Denmark2022-08-23 有效
57分杯處理系統國械備20160134號Roche   Diagnostics GmbHMaybachstraβe   30 - 71332 Waiblingen, Germany; Bernhardslaicher Weg 10-71686 Remseck Germany2022-08-23 變更
58緩沖液國械備20191200號Roche   Diagnostics GmbHSandhofer   Strasse 116,68305 Mannheim,Germany2022-08-23 變更
59肋骨牽開器國械備20220362號Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck Germany2022-08-23 有效
60髖關節手術工具國械備20210150號DePuy   Ireland UC請見附件“生產地址”。2022-08-22 變更
61鞘液濃縮液國械備20200676號Luminex   Corporation12212   Technology Blvd. Austin TX 78727 USA2022-08-22 變更
62牙科種植手術工具包國械備20171180號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2022-08-22 變更
63醫用退熱貼 國械備20220361號新タック化成株式會社香川県三豊市豊中町上高野4148番地2022-08-22 有效
64模型樹脂國械備20180735號bredent   GmbH & Co. KGWei?enhorner   Stra?e 2, 89250 Senden, Germany2022-08-22 變更
65模型樹脂國械備20180764號bredent   GmbH & Co. KGWei?enhorner   Stra?e 2, 89250 Senden, Germany2022-08-22 變更
66種植體安裝器械包國械備20171038號bredent   GmbH & Co. KGWeiβenhorner   Straβe 2 89250 Senden Germany2022-08-22 變更
67牙科磷酸鹽鑄造包埋材國械備20170097號bredent   GmbH & Co. KGWeiβenhorner   Straβe 2 89250 Senden Germany2022-08-22 變更
68牙科石膏國械備20180766號bredent   GmbH & Co. KGWei?enhorner   Stra?e 2, 89250 Senden, Germany2022-08-22 變更
69種植體螺絲起國械備20220360號Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2022-08-22 有效
70牙科器械鉗國械備20220359號Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-22 有效
71血管鉗國械備20220358號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-22 有效
72髓核鉗國械備20220357號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-22 有效
73牙科器械鉗國械備20220356號Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-19 有效
74牙科成形片套裝國械備20220355號Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-19 有效
75楔子國械備20220354號Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-19 有效
76ERG   抗體試劑（免疫組織化學）國械備20220353號 Ventana Medical Systems, Inc.1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2022-08-19 有效
77原位雜交用蛋白酶國械備20161983號Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson, AZ 85755 USA2022-08-19 變更
78正畸器械國械備20170055號Ortho   Technology, Inc.4614   Pet Lane Suite D-101 Lutz, FL USA 335592022-08-19 變更
79一次性使用末梢采血管國械備20210045號SARSTEDT   AG & Co. KGWinterborner   Stra?e，D-51588 Nümbrecht-Winterborn2022-08-19 變更
80自動樣本處理系統國械備20150277號Beckman   Coulter, Inc.8-14-30   Nagaminehigashi, Higashi-ku, Kumamoto-shi, Kumamoto-ken Japan2022-08-18 變更
81醫用防水彈力膠帶國械備20220352號3M   Company601   22nd Ave.South Brookings South Dakota 57006 USA2022-08-18 有效
82口內塑形刀套裝國械備20220351號Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-18 有效
83牙科測量桿國械備20220350號Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-18 有效
84牙科測量桿國械備20220349號Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-18 有效
85醫用檢查手套國械備20191084號O&M   Halyard, Inc.見附件。2022-08-18 變更
86矯形外科（骨科）手術器械國械備20160986號ulrich   GmbH & Co. KGBuchbrunnenweg   12, 89081 Ulm, Germany2022-08-18 變更
87骨科手術器械國械備20210369號ulrich   GmbH & Co. KGBuchbrunnenweg   12, 89081 Ulm, GERMANY2022-08-18 變更
88采血筆國械備20140036號華廣生技股份有限公司大慶廠臺中市南區大慶街二段100號2022-08-17 變更
89脊柱手術器械包國械備20170537號LDR   MEDICALParc   D’Entreprises du Grand Troyes, Quartier Europe de l’Ouest, 5 rue de Berlin   10300 SAINTE-SAVINE FRANCE2022-08-17 變更
90脊柱手術用工具國械備20151233號Zimmer   Trabecular Metal Technology, Inc.10   Pomeroy Rd, Parsippany, NJ, 07054, United States2022-08-17 變更
91測瓣器及其組件國械備20152152號Corcym   S.r.l.Via   Crescentino, sn 13040 SALUGGIA (VC) ITALY2022-08-16 變更
92牙科開口器國械備20220348號Dental   Monitoring SAS75   rue de Tocqueville, 75017 Paris, France2022-08-16 有效
93牙科鑷國械備20161298號Institut   Straumann AGWürttemberger   Strβe 23 78567 Fridingen, Deutschland2022-08-16 變更
94口腔科拋光保護帽國械備20220347號Institut   Straumann AG見附頁2022-08-16 有效
95瓣膜成形環測環器及組件國械備20160017號Corcym   S.r.l.Via   Crescentino sn 13040 SALUGGIA (VC) ITALY2022-08-16 變更
96測瓣器及其組件國械備20152082號Corcym   S.r.l.Via   Crescentino, sn 13040 SALUGGIA (VC) ITALY2022-08-16 變更
97正畸鉗 國械備20150219號3M   Unitek Corporation3232   N. Rockwell Street, Chicago, IL, 60618, United States2022-08-16 變更
98頭顱放射治療定位裝置國械備20190535號Medtec,   LLC dba CIVCO Radiotherapy1401   8th St. SE, Orange City, IA, 51041, United States2022-08-16 變更
99脊柱手術工具國械備20160220號Zimmer   Trabecular Metal Technology, Inc.10   Pomeroy Rd, Parsippany, NJ, 07054, United States2022-08-16 變更
100椎體撐開器國械備20151938號LDR   MEDICALH?tel   de Bureaux 1, 4 rue Gustave Eiffel 10430 ROSIERES PRES TROYES FRANCE2022-08-16 變更
101脊柱手術器械包國械備20170538號LDR   MEDICALParc   D’Entreprises du Grand Troyes, Quartier Europe de l’Ouest, 5 rue de Berlin   10300 SAINTE-SAVINE FRANCE2022-08-16 變更
102骨科手術器械國械備20220346號GIMMI   GmbHCarl-Zeiss-Strasse   6, 78532 Tuttlingen, Germany2022-08-12 有效
103X射線膠片國械備20220345號Ashland   Specialty Ingredients, G.P.1005   US Hwy 202/206 Bridgewater, NJ USA 088072022-08-11 有效
104樣本稀釋液   IMMULITE 1000 SHBG Sample Diluent國械備20160269號Siemens   Healthcare Diagnostics Products LimitedGlyn   Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom2022-08-11 變更
105樣本稀釋液   IMMULITE 1000 IgG/IgM (ID1) Sample Diluent國械備20160753號Siemens   Healthcare Diagnostics Products LimitedGlyn   Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom2022-08-11 變更
106膝關節手術工具國械備20220344號DePuy   Ireland UC詳見附頁2022-08-11 有效
107樣本密度分離液 國械備20170503號Oxford   Immunotec Ltd94C   Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, UK2022-08-11 變更
108細胞處理試劑盒國械備20181662號Oxford   Immunotec Ltd.94C   Innovation Drive Milton Park,Abingdon Oxfordshire,OX14 4RZ,UK2022-08-11 變更
109施夾鉗(不帶夾)國械備20200365號PETERS   SURGICAL 見附件22022-08-11 變更
110光固化牙齦屏障樹脂國械備20200329號Ultradent   Products, Inc. 505   West Ultradent Drive (10200 South), South Jordan, Utah 84095, USA 2022-08-11 變更
111旋入扳手國械備20151817號Ormco   Corporation1332   South Lone Hill Avenue Glendora, California 91740, USA2022-08-10 變更
112封片機國械備20220343號Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2022-08-10 有效
113切片清洗用蛋白酶國械備20170746號Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson, AZ 85755 USA2022-08-10 變更
114紅色復染染色液國械備20151707號Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson, AZ 85755 USA2022-08-10 變更
115抗體稀釋液國械備20190544號Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive Tucson, AZ 85755, USA2022-08-10 變更
116緩沖液國械備20151559號Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson, AZ 85755 USA;Sandhofer Strasse 116 68305 Mannheim, Germany2022-08-10 變更
117脫蠟液國械備20151923號Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson, AZ 85755 USA2022-08-10 變更
118切片清洗用蛋白酶國械備20170747號Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson, AZ 85755 USA2022-08-10 變更
119p16/Ki-67檢測試劑盒（免疫細胞化學法） 國械備20190125號Roche   Diagnostics GmbH1910E.Innovation   Park Drive Tucson,Arizona 85755 USA2022-08-10 變更
120滑錘國械備20220342號Zimmer,   Inc.1800W.   Center Street, Warsaw, Indiana 46580, USA2022-08-10 有效
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124帕巾鉗國械備20200384號CEATEC   Medizintechnik GmbHUntere   Hauptstr.6  78573 Wurmlingen2022-08-10 變更
125原位雜交用蛋白酶國械備20161258號Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson, AZ 85755 USA2022-08-09 變更
126細胞角蛋白（廣譜）抗體試劑（免疫組織化學）國械備20190048號Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson,Arizona 85755 USA2022-08-09 變更
127CD99抗體試劑（免疫組織化學）國械備20180446號Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2022-08-09 變更
128MUC-1抗體試劑（免疫組織化學）國械備20180601號Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive, Tucson, AZ, 85755, USA2022-08-09 變更
129E-Cadherin   抗體試劑（免疫組織化學）國械備20180249號Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2022-08-09 變更
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131原位雜交用蛋白酶國械備20162014號Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson, AZ 85755 USA2022-08-09 變更
132生物顯微鏡國械備20220341號Carl   Zeiss Microscopy GmbHKǒnigsallee   9-21, 37081 Gǒttingen, Germany2022-08-09 有效
133EMA抗體試劑（免疫組織化學）國械備20180447號Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2022-08-09 變更
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136鉆針深度停止器國械備20161063號MIS   Implants Technologies Ltd.Bar   Lev Industrial Park, 2015600 Israel2022-08-09 變更
137刮匙國械備20220339號JFU   INDUSTRIESLiaqat   Ali Road, Link M.A Jinnah Road, Indsutrial Estate, Sialkot, Punjab, 51310,   Pakistan2022-08-09 有效
138醫用退熱貼 國械備20220338號達文西生醫科技股份有限公司臺灣屏東縣屏東市清溪裏和生路三段1006號2022-08-09 有效
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144脊柱后路內固定系統手術工具國械備20170833號bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2022-08-09 變更
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147脊柱外科手術工具 國械備20161352號Zimmer   Biomet Spine, Inc.10225   Westmoor Drive, Westminster, Colorado 80021, USA2022-08-09 變更
148腰椎融合器手術工具國械備20170101號Bricon   GmbHWasserkuppenstrasse   29-31 - 36043 Fulda Germany2022-08-09 變更
149根管充填器國械備20150796號Maillefer   instruments Holding SàrlChemin   du Verger 3，1338 Ballaigues Switzerland2022-08-09 變更
150人體定位袋國械備20180866號Medtec,   LLC dba CIVCO Radiotherapy1401   8th St.SE,Orange City,IA,51041,United States2022-08-09 變更
151組織鉗國械備20170884號CEATEC   Medizintechnik GmbHUntere   Hauptstra?e 6 DE 78573 Wurmlingen,Germany2022-08-08 變更
152刮匙國械備20170878號CEATEC   Medizintechnik GmbHUntere   Hauptstra?e 6 DE 78573 Wurmlingen,Germany2022-08-08 變更
153剝離器國械備20170877號CEATEC   Medizintechnik GmbHUntere   Hauptstra?e 6 DE 78573 Wurmlingen,Germany2022-08-08 變更
154外科牽開器國械備20170876號CEATEC   Medizintechnik GmbHUntere   Hauptstra?e 6 DE 78573 Wurmlingen,Germany2022-08-08 變更
155醫用檢查手套國械備20170894號Sri   Trang Gloves (Thailand) Public Company Limited110   Kanjanavanit Road, Pahtong, Hatyai, Songkhla 90230, Thailand2022-08-08 變更
156醫用檢查手套國械備20170895號Sri   Trang Gloves (Thailand) Public Company Limited110   Kanjanavanit Road, Pahtong, Hatyai, Songkhla 90230, Thailand2022-08-08 變更
157醫用檢查手套國械備20180820號Sri   Trang Gloves (Thailand) Public Company Limited189   Moo 7, Phaiwat, Kanjanadit, Suratthani, 84160, THAILAND2022-08-08 變更
158醫用檢查手套國械備20180819號Sri   Trang Gloves (Thailand) Public Company Limited189   Moo 7, Phaiwat, Kanjanadit, Suratthani, 84160, THAILAND2022-08-08 變更
159CD5檢測試劑國械備20220335號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-08-08 有效
160骨用牽開器國械備20151283號Boss   Instruments, Ltd104   Sommerfield Drive Gordonsville,VA 229422022-08-08 變更
161內窺鏡咬口國械備20200713號富士フイルム株式會社204   Moo 7, Tambol Tatoom Amphur Srimahaphot, Prachinburi, Thailand2022-08-05 無效
162小瞳孔擴大器國械備20220334號Rumex   International Co.34   Sibirsky Tract, Str. Building 4， 420029, Kazan, Republic of Tatarstan, Russia2022-08-05 有效
163扭力扳手國械備20220333號X-Nav   Technologies, LLC1555   Bustard Road, Suite 75 & 110 Lansdale, Pennsylvania 19446 United States2022-08-05 有效
164螺絲起國械備20220332號X-Nav   Technologies, LLC1555   Bustard Road, Suite 75 & 110 Lansdale, Pennsylvania 19446 United States2022-08-05 有效
165醫用透氣膠帶國械備20160588號日東電工株式會社宮城県大崎市巖出山下野目字砂田101番地2022-08-05 變更
166乳腺加壓彈力繃帶國械備20220331號Manifattura   CI-ZETA S.R.LVia Luigi   Fassati, 11, I-25050 Passirano (BS) - ITALY2022-08-05 有效
167生物顯微鏡國械備20220330號Carl   Zeiss Microscopy GmbHKǒnigsallee   9-21, 37081 Gǒttingen, Germany2022-08-04 有效
168牙科種植系統手術工具國械備20170857號SDM   Co., Ltd110   Commercialization Building 3dong, 333, Cheomdangwagi-ro, Buk-gu, Gwangju,   Korea2022-08-04 變更
169口腔科手術器械國械備20220329號LEGEND   GROUPAeminabad   Road,Village Adam Daraz,Sialkot-Pakistan2022-08-04 有效
170骨科手術器械國械備20180405號Boss   Instruments, Ltd104   Sommerfield Drive,Gordonsville, VA22942,Unites States2022-08-04 變更
171耳鼻喉科手術器械國械備20160604號Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany2022-08-04 變更
172螺絲起國械備20151268號Thommen   Medical AGNeckarsulmstrasse   28, 2540 Grenchen, Switzerland2022-08-04 變更
173牙科種植掃描體國械備20181655號Thommen   Medical AGNeckarsulmstrasse   28,2540 Grenchen Switzerland2022-08-04 變更
174脊柱手術器械包國械備20170569號LDR   MEDICAL Parc   D’Entreprises du Grand Troyes, Quartier Europe de l’Ouest, 5 rue de Berlin   10300 SAINTE-SAVINE FRANCE2022-08-04 變更
175脊柱手術器械包國械備20170522號LDR   MEDICALParc   D’Entreprises du Grand Troyes, Quartier Europe de l’Ouest, 5 rue de Berlin   10300 SAINTE-SAVINE FRANCE2022-08-04 變更
176機用螺絲刀國械備20160894號Thommen   Medical AGNeckarsulmstrasse   28,2540 Grenchen Switzerland2022-08-04 變更
177剝離器國械備20220160號Grace   Medical, Inc.8500   Wolf Lake Drive, Suite 110 Memphis, Tennessee 38133, USA2022-08-04 變更
178正畸鉗國械備20170696號株式會社シオダ櫪木縣那須鳥山市東原53番地2022-08-04 變更
179顯微持針鉗國械備20220328號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-04 有效
180顯微鑷國械備20220327號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-04 有效
181手術頭架國械備20220326號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-04 有效
182手術剪國械備20220325號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-04 有效
183顯微剪國械備20220324號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-04 有效
184脊柱用手術工具國械備20220323號Medtronic   Sofamor Danek USA, Inc4340   Swinnea Road Memphis, TN 38118, USA; 2500 Silveus Crossing Warsaw, IN 46582,   USA2022-08-03 有效
185脊柱用手術工具國械備20170359號Tecomet,   Inc.5307   95th, Ave KENOSHA, WI USA 531442022-08-03 變更
186手術頭架國械備20170819號Stryker   Leibinger GmbH & Co. KGB?tzinger   Str. 41 79111 Freiburg Deutschland2022-08-03 變更
187封片機國械備20220322號Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2022-08-03 有效
188清洗液國械備20210331號IMMUNODIAGNOSTIC   SYSTEMS S.A.Rue   Ernest Solvay 101 4000 LIEGE BELGIUM2022-08-03 變更
189緩沖液國械備20140298號Radiometer   Medical ApS生產地址1：Aakandevej   21, DK-2700 Bronshoj, Denmark
   
    生產地址2：Stalowa 6, Stargard 73-110, Poland
   
   		2022-08-03 變更
190激發液   IDS-iSYS Trigger Set國械備20150840號Immunodiagnostic   Systems SArue   Ernest Solvay 101 4000 Liège, Belgium2022-08-03 變更
191顯微眼用鑷國械備20210413號Rumex   International Co.34   Sibirsky Tract, Str. Building 4    420029, Kazan, Republic of Tatarstan, Russia2022-08-02 變更
192顯微眼用拉鉤國械備20210415號Rumex   International Co.34   Sibirsky Tract, Str. Building 4    420029, Kazan, Republic of Tatarstan, Russia2022-08-02 變更
193標記環國械備20220321號Rumex   International Co.34   Sibirsky Tract, Str. Building 4， 420029, Kazan, Republic of Tatarstan, Russia2022-08-02 有效
194咬切器國械備20220320號Rumex   International Co.34   Sibirsky Tract, Str. Building 4， 420029, Kazan, Republic of Tatarstan, Russia2022-08-02 有效
195醫用墊單國械備20220319號PAUL   HARTMANN AG見附件2022-08-02 有效
196骨關節手術器械國械備20210271號Stryker   Endoscopy5900   Optical Court, San Jose, CA 95138, USA2022-08-02 變更
197骨科外固定支架手術工具國械備20180144號Orthofix   SrlVia   delle Nazioni, 9, 37012 Bussolengo - VR, Italy2022-08-02 變更
198髓內手術安裝工具國械備20160319號Orthofix   SrlVia   delle Nazioni 9, 37012 Bussolengo-VR2022-08-02 變更
199髖關節手術位置固定架及工具國械備20161687號Orthofix   SrlVia   delle Nazioni, 9, 37012 Bussolengo - VR, Italy2022-08-02 變更
200醫用檢查手套國械備20171166號Henry   Schein Services GmbH10   Soi 10, Phetkasem Road, Hatyai, Songkhla 90110, Thailand2022-08-02 變更
201牙齦刀國械備20190665號SIC   invent AGTrophagener   Weg 25, 32657 Lemgo, Germany2022-08-02 變更
202螺絲起國械備20150871號???????(?)66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2022-08-02 變更
203牙科醫師椅國械備20220318號Osstem   Implant Co., Ltd.192,   Haebong-ro, Danwon-gu. Ansan-si, Gyeonggi-do, Republic of Korea2022-08-02 有效
204腦電（肌電）導聯線國械備20220317號Technomed   EuropeAmerikalaan   71 6199 AE Maastricht Airport The Netherlands2022-08-01 有效

     來源：國家藥品監督管理局   

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