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2022年8月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息
作者：admin     時(shí)間：2022-09-11 14:50:37

 發(fā)布時(shí)間：2022-09-08


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器械鉗國(guó)械備20171065號(hào)Boston   Scientific Corporation10700   Bren Road West, Minnetonka, MN USA 553432022-08-31 變更
2導(dǎo)引針國(guó)械備20171015號(hào)Boston   Scientific Corporation10700   Bren Road West, Minnetonka, MN USA 553432022-08-31 變更
3機(jī)用螺絲刀國(guó)械備20170338號(hào)DENTSPLY   Implants Manufacturing GmbHAminogatan   1, PO Box 14, 43121 M?lndal,SWEDEN2022-08-31 變更
4全自動(dòng)樣品處理系統(tǒng)國(guó)械備20220379號(hào)Inpeco   S.A.Via   Givoletto 15 I-10040, Val della Torre (TO), Italy2022-08-31 有效
5測(cè)瓣器組件國(guó)械備20210477號(hào)Corcym   S.r.l.Via   Crescentino sn, 13040 Saluggia (VC) ITALY2022-08-31 變更
6口腔燈國(guó)械備20150446號(hào)G.   COMM S.r. l.VIA   DONIZETTI 22 I-20872 CORNATE D’ADDA(MB)2022-08-31 變更
7口腔燈國(guó)械備20151258號(hào)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(guó)械備20220034號(hào)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(nèi)提升器國(guó)械備20190248號(hào)SAWUAT   SURGICALQadoos   Street Kacha Shahab Pura, Small Industrial Area, Sialkot - Pakistan2022-08-31 變更
10牙科種植手術(shù)取模工具包國(guó)械備20170506號(hào)Thommen   Medical AGNeckarsulmstrasse   28,2540 Grenchen Switzerland2022-08-30 變更
11醫(yī)用檢查手套國(guó)械備20161050號(hào)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(shù)器械國(guó)械備20170300號(hào)MEDESY   SRLVIALE   DELL’INDUSTRIA 1-ZONA INDUSTRIALE-33085 MANIAGO(PN)2022-08-30 變更
13基礎(chǔ)外科手術(shù)器械國(guó)械備20170289號(hào)MEDESY   SRLVIALE   DELL’INDUSTRIA 1-ZONA INDUSTRIALE-33085 MANIAGO(PN)2022-08-30 變更
14口腔科手術(shù)器械國(guó)械備20170304號(hào)MEDESY   SRLVIALE   DELL’INDUSTRIA 1-ZONA INDUSTRIALE-33085 MANIAGO(PN)2022-08-30 變更
15集尿袋國(guó)械備20161090號(hào)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(guó)械備20151901號(hào)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(guó)械備20171089號(hào)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(guó)械備20160432號(hào)Flexicare   Medical LtdParkway   Harlow Business Park Harlow CM19 5FR United Kingdom2022-08-30 變更
19引流袋國(guó)械備20170603號(hào)Serres   OyKeskustie   23, 61850 Kauhajoki As Finland2022-08-29 變更
20引流袋系統(tǒng)國(guó)械備20210410號(hào)Serres   OyKeskustie   23, FI-61850 Kauhajoki as, Finland2022-08-29 變更
21CEA抗體試劑（免疫組織化學(xué)）國(guó)械備20220378號(hào)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(xué)）國(guó)械備20220377號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin CA 95677 USA2022-08-29 有效
23全自動(dòng)免疫組化獨(dú)立控溫單獨(dú)滴染染色機(jī)國(guó)械備20220376號(hào)Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA2022-08-29 有效
24醫(yī)用干式激光膠片國(guó)械備20210211號(hào)Agfa   NVSeptestraat   27, 2640 Mortsel, Belgium; 1658 Bushy Park Road, Goose Creek, South Carolina   29445, USA2022-08-29 無(wú)效
25醫(yī)用干式激光膠片國(guó)械備20210212號(hào) Agfa NV Septestraat   27, 2640 Mortsel, Belgium; 1658 Bushy Park Road, Goose Creek, South Carolina   29445, USA2022-08-29 無(wú)效
26脊柱手術(shù)器械包國(guó)械備20171186號(hào)冠亞生技股份有限公司臺(tái)北市內(nèi)湖區(qū)洲子街50號(hào)2022-08-29 變更
27耳鼻喉科手術(shù)器械包國(guó)械備20200361號(hào)Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany2022-08-29 變更
28成形片國(guó)械備20220375號(hào)Dental   Art Innovations Pty Ltd1385   Decision Street, Vista, CA 92081 USA2022-08-29 有效
29止血夾國(guó)械備20220374號(hào)Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-26 有效
30椎板咬骨鉗國(guó)械備20220373號(hào)Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-26 有效
31牙科種植專用器械包國(guó)械備20161332號(hào)DIO   Corporation66,   Centum seo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA2022-08-26 變更
32種植體掃描體國(guó)械備20161179號(hào)DIO   Corporation66,   Centumseo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA2022-08-26 變更
33轉(zhuǎn)移帽國(guó)械備20161140號(hào)DIO   Corporation66,   Centumseo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA2022-08-26 變更
34抗交叉反應(yīng)性糖類決定簇（CCD）抗體吸附劑國(guó)械備20190588號(hào)EUROIMMUN   Medizinische Labordiagnostika AGSeekamp   31, D-23560 Lübeck, Germany2022-08-26 變更
35引流袋國(guó)械備20151343號(hào)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(guó)械備20220372號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-25 有效
37牙科用鑷國(guó)械備20220371號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-25 有效
38膝關(guān)節(jié)手術(shù)工具國(guó)械備20210189號(hào)DePuy   Ireland UC請(qǐng)見附件“生產(chǎn)地址”。2022-08-25 變更
39腕關(guān)節(jié)固定器國(guó)械備20210578號(hào)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(guó)械備20200428號(hào)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(guó)械備20200569號(hào)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(guó)械備20220370號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-25 有效
43生物顯微鏡國(guó)械備20220341號(hào)Carl   Zeiss Microscopy GmbHKǒnigsallee   9-21, 37081 Gǒttingen, Germany2022-08-25 變更
44生物顯微鏡國(guó)械備20220330號(hào)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(guó)械備20150611號(hào)Intersurgical   LtdCrane   House, Molly Millars Lane, Wokingham, Berkshire, RG41 2RZ, UK2022-08-25 變更
46防褥瘡床墊國(guó)械備20150035號(hào)HERNIAMESH   SRLIT-10034   CHIVASSO(TO)-VIA FRATELLI MELIGA,I/C2022-08-25 變更
47導(dǎo)引針國(guó)械備20170718號(hào)HERNIAMESH   SRLIT-10034   CHIVASSO(TO)-VIA FRATELLI MELIGA,1/C 2022-08-25 變更
48骨科牽引架20210276號(hào)Stryker   Endoscopy見附件2022-08-25 變更
49醫(yī)用光學(xué)生物顯微鏡國(guó)械備20220027號(hào) 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(guó)械備20220369號(hào)Paul   Hartmann AGP.I.   Pla d'en Boet II, c/Carrasco i Formiguera, 48, 08302 Mataró (Barcelona),   SPAIN2022-08-24 有效
51醫(yī)用檢查手套國(guó)械備20160956號(hào)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(guó)械備20220004號(hào)Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2022-08-23 變更
53成形片夾國(guó)械備20220367號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-23 有效
54橡皮障國(guó)械備20220365號(hào)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(guó)械備20220364號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-23 有效
56給藥指套國(guó)械備20220363號(hào)H.Dam   K?rgaard A/SBorupvang   9，2750 Ballerup，Denmark2022-08-23 有效
57分杯處理系統(tǒng)國(guó)械備20160134號(hào)Roche   Diagnostics GmbHMaybachstraβe   30 - 71332 Waiblingen, Germany; Bernhardslaicher Weg 10-71686 Remseck Germany2022-08-23 變更
58緩沖液國(guó)械備20191200號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116,68305 Mannheim,Germany2022-08-23 變更
59肋骨牽開器國(guó)械備20220362號(hào)Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck Germany2022-08-23 有效
60髖關(guān)節(jié)手術(shù)工具國(guó)械備20210150號(hào)DePuy   Ireland UC請(qǐng)見附件“生產(chǎn)地址”。2022-08-22 變更
61鞘液濃縮液國(guó)械備20200676號(hào)Luminex   Corporation12212   Technology Blvd. Austin TX 78727 USA2022-08-22 變更
62牙科種植手術(shù)工具包國(guó)械備20171180號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2022-08-22 變更
63醫(yī)用退熱貼 國(guó)械備20220361號(hào)新タック化成株式會(huì)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(guó)械備20180735號(hào)bredent   GmbH & Co. KGWei?enhorner   Stra?e 2, 89250 Senden, Germany2022-08-22 變更
65模型樹脂國(guó)械備20180764號(hào)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(guó)械備20171038號(hào)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(guó)械備20170097號(hào)bredent   GmbH & Co. KGWeiβenhorner   Straβe 2 89250 Senden Germany2022-08-22 變更
68牙科石膏國(guó)械備20180766號(hào)bredent   GmbH & Co. KGWei?enhorner   Stra?e 2, 89250 Senden, Germany2022-08-22 變更
69種植體螺絲起國(guó)械備20220360號(hào)Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2022-08-22 有效
70牙科器械鉗國(guó)械備20220359號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-22 有效
71血管鉗國(guó)械備20220358號(hào)Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-22 有效
72髓核鉗國(guó)械備20220357號(hào)Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-22 有效
73牙科器械鉗國(guó)械備20220356號(hào)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(guó)械備20220355號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-19 有效
75楔子國(guó)械備20220354號(hào)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(xué)）國(guó)械備20220353號(hào) 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(guó)械備20161983號(hào)Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson, AZ 85755 USA2022-08-19 變更
78正畸器械國(guó)械備20170055號(hào)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(guó)械備20210045號(hào)SARSTEDT   AG & Co. KGWinterborner   Stra?e，D-51588 Nümbrecht-Winterborn2022-08-19 變更
80自動(dòng)樣本處理系統(tǒng)國(guó)械備20150277號(hào)Beckman   Coulter, Inc.8-14-30   Nagaminehigashi, Higashi-ku, Kumamoto-shi, Kumamoto-ken Japan2022-08-18 變更
81醫(yī)用防水彈力膠帶國(guó)械備20220352號(hào)3M   Company601   22nd Ave.South Brookings South Dakota 57006 USA2022-08-18 有效
82口內(nèi)塑形刀套裝國(guó)械備20220351號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-18 有效
83牙科測(cè)量桿國(guó)械備20220350號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-18 有效
84牙科測(cè)量桿國(guó)械備20220349號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092022-08-18 有效
85醫(yī)用檢查手套國(guó)械備20191084號(hào)O&M   Halyard, Inc.見附件。2022-08-18 變更
86矯形外科（骨科）手術(shù)器械國(guó)械備20160986號(hào)ulrich   GmbH & Co. KGBuchbrunnenweg   12, 89081 Ulm, Germany2022-08-18 變更
87骨科手術(shù)器械國(guó)械備20210369號(hào)ulrich   GmbH & Co. KGBuchbrunnenweg   12, 89081 Ulm, GERMANY2022-08-18 變更
88采血筆國(guó)械備20140036號(hào)華廣生技股份有限公司大慶廠臺(tái)中市南區(qū)大慶街二段100號(hào)2022-08-17 變更
89脊柱手術(shù)器械包國(guó)械備20170537號(hào)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(shù)用工具國(guó)械備20151233號(hào)Zimmer   Trabecular Metal Technology, Inc.10   Pomeroy Rd, Parsippany, NJ, 07054, United States2022-08-17 變更
91測(cè)瓣器及其組件國(guó)械備20152152號(hào)Corcym   S.r.l.Via   Crescentino, sn 13040 SALUGGIA (VC) ITALY2022-08-16 變更
92牙科開口器國(guó)械備20220348號(hào)Dental   Monitoring SAS75   rue de Tocqueville, 75017 Paris, France2022-08-16 有效
93牙科鑷國(guó)械備20161298號(hào)Institut   Straumann AGWürttemberger   Strβe 23 78567 Fridingen, Deutschland2022-08-16 變更
94口腔科拋光保護(hù)帽國(guó)械備20220347號(hào)Institut   Straumann AG見附頁(yè)2022-08-16 有效
95瓣膜成形環(huán)測(cè)環(huán)器及組件國(guó)械備20160017號(hào)Corcym   S.r.l.Via   Crescentino sn 13040 SALUGGIA (VC) ITALY2022-08-16 變更
96測(cè)瓣器及其組件國(guó)械備20152082號(hào)Corcym   S.r.l.Via   Crescentino, sn 13040 SALUGGIA (VC) ITALY2022-08-16 變更
97正畸鉗 國(guó)械備20150219號(hào)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(guó)械備20190535號(hào)Medtec,   LLC dba CIVCO Radiotherapy1401   8th St. SE, Orange City, IA, 51041, United States2022-08-16 變更
99脊柱手術(shù)工具國(guó)械備20160220號(hào)Zimmer   Trabecular Metal Technology, Inc.10   Pomeroy Rd, Parsippany, NJ, 07054, United States2022-08-16 變更
100椎體撐開器國(guó)械備20151938號(hào)LDR   MEDICALH?tel   de Bureaux 1, 4 rue Gustave Eiffel 10430 ROSIERES PRES TROYES FRANCE2022-08-16 變更
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104樣本稀釋液   IMMULITE 1000 SHBG Sample Diluent國(guó)械備20160269號(hào)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(guó)械備20160753號(hào)Siemens   Healthcare Diagnostics Products LimitedGlyn   Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom2022-08-11 變更
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119p16/Ki-67檢測(cè)試劑盒（免疫細(xì)胞化學(xué)法） 國(guó)械備20190125號(hào)Roche   Diagnostics GmbH1910E.Innovation   Park Drive Tucson,Arizona 85755 USA2022-08-10 變更
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127CD99抗體試劑（免疫組織化學(xué)）國(guó)械備20180446號(hào)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(xué)）國(guó)械備20180601號(hào)Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive, Tucson, AZ, 85755, USA2022-08-09 變更
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137刮匙國(guó)械備20220339號(hào)JFU   INDUSTRIESLiaqat   Ali Road, Link M.A Jinnah Road, Indsutrial Estate, Sialkot, Punjab, 51310,   Pakistan2022-08-09 有效
138醫(yī)用退熱貼 國(guó)械備20220338號(hào)達(dá)文西生醫(yī)科技股份有限公司臺(tái)灣屏東縣屏東市清溪裏和生路三段1006號(hào)2022-08-09 有效
139骨鑿國(guó)械備20220337號(hào)JFU   INDUSTRIESLiaqat   Ali Road, Link M.A Jinnah Road, Indsutrial Estate, Sialkot, Punjab, 51310,   Pakistan2022-08-09 有效
140咬骨鉗國(guó)械備20171018號(hào)bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2022-08-09 變更
141持針鉗國(guó)械備20220336號(hào)Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck2022-08-09 有效
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144脊柱后路內(nèi)固定系統(tǒng)手術(shù)工具國(guó)械備20170833號(hào)bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2022-08-09 變更
145頸椎前路固定板系統(tǒng)手術(shù)工具國(guó)械備20170832號(hào)Bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2022-08-09 變更
146帶固定板的頸椎融合器手術(shù)工具國(guó)械備20170867號(hào)Bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2022-08-09 變更
147脊柱外科手術(shù)工具 國(guó)械備20161352號(hào)Zimmer   Biomet Spine, Inc.10225   Westmoor Drive, Westminster, Colorado 80021, USA2022-08-09 變更
148腰椎融合器手術(shù)工具國(guó)械備20170101號(hào)Bricon   GmbHWasserkuppenstrasse   29-31 - 36043 Fulda Germany2022-08-09 變更
149根管充填器國(guó)械備20150796號(hào)Maillefer   instruments Holding SàrlChemin   du Verger 3，1338 Ballaigues Switzerland2022-08-09 變更
150人體定位袋國(guó)械備20180866號(hào)Medtec,   LLC dba CIVCO Radiotherapy1401   8th St.SE,Orange City,IA,51041,United States2022-08-09 變更
151組織鉗國(guó)械備20170884號(hào)CEATEC   Medizintechnik GmbHUntere   Hauptstra?e 6 DE 78573 Wurmlingen,Germany2022-08-08 變更
152刮匙國(guó)械備20170878號(hào)CEATEC   Medizintechnik GmbHUntere   Hauptstra?e 6 DE 78573 Wurmlingen,Germany2022-08-08 變更
153剝離器國(guó)械備20170877號(hào)CEATEC   Medizintechnik GmbHUntere   Hauptstra?e 6 DE 78573 Wurmlingen,Germany2022-08-08 變更
154外科牽開器國(guó)械備20170876號(hào)CEATEC   Medizintechnik GmbHUntere   Hauptstra?e 6 DE 78573 Wurmlingen,Germany2022-08-08 變更
155醫(yī)用檢查手套國(guó)械備20170894號(hào)Sri   Trang Gloves (Thailand) Public Company Limited110   Kanjanavanit Road, Pahtong, Hatyai, Songkhla 90230, Thailand2022-08-08 變更
156醫(yī)用檢查手套國(guó)械備20170895號(hào)Sri   Trang Gloves (Thailand) Public Company Limited110   Kanjanavanit Road, Pahtong, Hatyai, Songkhla 90230, Thailand2022-08-08 變更
157醫(yī)用檢查手套國(guó)械備20180820號(hào)Sri   Trang Gloves (Thailand) Public Company Limited189   Moo 7, Phaiwat, Kanjanadit, Suratthani, 84160, THAILAND2022-08-08 變更
158醫(yī)用檢查手套國(guó)械備20180819號(hào)Sri   Trang Gloves (Thailand) Public Company Limited189   Moo 7, Phaiwat, Kanjanadit, Suratthani, 84160, THAILAND2022-08-08 變更
159CD5檢測(cè)試劑國(guó)械備20220335號(hào)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(guó)械備20151283號(hào)Boss   Instruments, Ltd104   Sommerfield Drive Gordonsville,VA 229422022-08-08 變更
161內(nèi)窺鏡咬口國(guó)械備20200713號(hào)富士フイルム株式會(huì)社204   Moo 7, Tambol Tatoom Amphur Srimahaphot, Prachinburi, Thailand2022-08-05 無(wú)效
162小瞳孔擴(kuò)大器國(guó)械備20220334號(hào)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(guó)械備20220333號(hào)X-Nav   Technologies, LLC1555   Bustard Road, Suite 75 & 110 Lansdale, Pennsylvania 19446 United States2022-08-05 有效
164螺絲起國(guó)械備20220332號(hào)X-Nav   Technologies, LLC1555   Bustard Road, Suite 75 & 110 Lansdale, Pennsylvania 19446 United States2022-08-05 有效
165醫(yī)用透氣膠帶國(guó)械備20160588號(hào)日東電工株式會(huì)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(guó)械備20220331號(hào)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(guó)械備20220330號(hào)Carl   Zeiss Microscopy GmbHKǒnigsallee   9-21, 37081 Gǒttingen, Germany2022-08-04 有效
168牙科種植系統(tǒng)手術(shù)工具國(guó)械備20170857號(hào)SDM   Co., Ltd110   Commercialization Building 3dong, 333, Cheomdangwagi-ro, Buk-gu, Gwangju,   Korea2022-08-04 變更
169口腔科手術(shù)器械國(guó)械備20220329號(hào)LEGEND   GROUPAeminabad   Road,Village Adam Daraz,Sialkot-Pakistan2022-08-04 有效
170骨科手術(shù)器械國(guó)械備20180405號(hào)Boss   Instruments, Ltd104   Sommerfield Drive,Gordonsville, VA22942,Unites States2022-08-04 變更
171耳鼻喉科手術(shù)器械國(guó)械備20160604號(hào)Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany2022-08-04 變更
172螺絲起國(guó)械備20151268號(hào)Thommen   Medical AGNeckarsulmstrasse   28, 2540 Grenchen, Switzerland2022-08-04 變更
173牙科種植掃描體國(guó)械備20181655號(hào)Thommen   Medical AGNeckarsulmstrasse   28,2540 Grenchen Switzerland2022-08-04 變更
174脊柱手術(shù)器械包國(guó)械備20170569號(hào)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(shù)器械包國(guó)械備20170522號(hào)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(jī)用螺絲刀國(guó)械備20160894號(hào)Thommen   Medical AGNeckarsulmstrasse   28,2540 Grenchen Switzerland2022-08-04 變更
177剝離器國(guó)械備20220160號(hào)Grace   Medical, Inc.8500   Wolf Lake Drive, Suite 110 Memphis, Tennessee 38133, USA2022-08-04 變更
178正畸鉗國(guó)械備20170696號(hào)株式會(huì)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(guó)械備20220328號(hào)Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-04 有效
180顯微鑷國(guó)械備20220327號(hào)Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-04 有效
181手術(shù)頭架國(guó)械備20220326號(hào)Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-04 有效
182手術(shù)剪國(guó)械備20220325號(hào)Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-04 有效
183顯微剪國(guó)械備20220324號(hào)Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-08-04 有效
184脊柱用手術(shù)工具國(guó)械備20220323號(hào)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(shù)工具國(guó)械備20170359號(hào)Tecomet,   Inc.5307   95th, Ave KENOSHA, WI USA 531442022-08-03 變更
186手術(shù)頭架國(guó)械備20170819號(hào)Stryker   Leibinger GmbH & Co. KGB?tzinger   Str. 41 79111 Freiburg Deutschland2022-08-03 變更
187封片機(jī)國(guó)械備20220322號(hào)Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2022-08-03 有效
188清洗液國(guó)械備20210331號(hào)IMMUNODIAGNOSTIC   SYSTEMS S.A.Rue   Ernest Solvay 101 4000 LIEGE BELGIUM2022-08-03 變更
189緩沖液國(guó)械備20140298號(hào)Radiometer   Medical ApS生產(chǎn)地址1：Aakandevej   21, DK-2700 Bronshoj, Denmark
   
    生產(chǎn)地址2：Stalowa 6, Stargard 73-110, Poland
   
   		2022-08-03 變更
190激發(fā)液   IDS-iSYS Trigger Set國(guó)械備20150840號(hào)Immunodiagnostic   Systems SArue   Ernest Solvay 101 4000 Liège, Belgium2022-08-03 變更
191顯微眼用鑷國(guó)械備20210413號(hào)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(guó)械備20210415號(hào)Rumex   International Co.34   Sibirsky Tract, Str. Building 4    420029, Kazan, Republic of Tatarstan, Russia2022-08-02 變更
193標(biāo)記環(huán)國(guó)械備20220321號(hào)Rumex   International Co.34   Sibirsky Tract, Str. Building 4， 420029, Kazan, Republic of Tatarstan, Russia2022-08-02 有效
194咬切器國(guó)械備20220320號(hào)Rumex   International Co.34   Sibirsky Tract, Str. Building 4， 420029, Kazan, Republic of Tatarstan, Russia2022-08-02 有效
195醫(yī)用墊單國(guó)械備20220319號(hào)PAUL   HARTMANN AG見附件2022-08-02 有效
196骨關(guān)節(jié)手術(shù)器械國(guó)械備20210271號(hào)Stryker   Endoscopy5900   Optical Court, San Jose, CA 95138, USA2022-08-02 變更
197骨科外固定支架手術(shù)工具國(guó)械備20180144號(hào)Orthofix   SrlVia   delle Nazioni, 9, 37012 Bussolengo - VR, Italy2022-08-02 變更
198髓內(nèi)手術(shù)安裝工具國(guó)械備20160319號(hào)Orthofix   SrlVia   delle Nazioni 9, 37012 Bussolengo-VR2022-08-02 變更
199髖關(guān)節(jié)手術(shù)位置固定架及工具國(guó)械備20161687號(hào)Orthofix   SrlVia   delle Nazioni, 9, 37012 Bussolengo - VR, Italy2022-08-02 變更
200醫(yī)用檢查手套國(guó)械備20171166號(hào)Henry   Schein Services GmbH10   Soi 10, Phetkasem Road, Hatyai, Songkhla 90110, Thailand2022-08-02 變更
201牙齦刀國(guó)械備20190665號(hào)SIC   invent AGTrophagener   Weg 25, 32657 Lemgo, Germany2022-08-02 變更
202螺絲起國(guó)械備20150871號(hào)???????(?)66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2022-08-02 變更
203牙科醫(yī)師椅國(guó)械備20220318號(hào)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(dǎo)聯(lián)線國(guó)械備20220317號(hào)Technomed   EuropeAmerikalaan   71 6199 AE Maastricht Airport The Netherlands2022-08-01 有效

     來源：國(guó)家藥品監(jiān)督管理局   

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