2017年2月進口第一類醫(yī)療器械產(chǎn)品備案信息

1、20172017年年2 2月月進進口口第第一一類類醫(yī)醫(yī)療療器器械械產(chǎn)產(chǎn)品品備備案案信信息息序序號號產(chǎn)產(chǎn)品品名名稱稱備備案案人人名名稱稱備備案案號號生生產(chǎn)產(chǎn)地地址址備備案案日日期期狀狀態(tài)態(tài)1鞘液濃縮液Luminex Corporation 國械備20160091號12212 TechnologyBlvd, Austin, Texas78727 USA2017-02-28 變更2包埋機精機株式會社 國械備20170146號75-5, IMOJIYA,CHIKUMA-CITY,NAGANO.PREF.,JAPAN2017-02-28 有效3 彈性柔棉寬膠帶 3M Japan LimitedHealt

2、h CareCompany 國械備20150483號5500 Ooaza-Osanagi, Higashine-shi, Yamagata, 999-3737 Japan2017-02-28 變更4負氣壓式骨折固定保護氣墊OPED GmbH國械備20170145號Medizinpark 1 83626Valley/OberlaindernGERMANY2017-02-28 有效5兩件式造口袋ConvaTec Limited國械備20140099號First Avenue,Deeside IndustrialPark, Deeside,Flintshire, CH5 2NU,United Kin

3、gdom;Carretera Sanchez,Km. 18.5 ParqueIndustrial Itabo, S.A.Buidings 23, 29, 30Haina, San Cristobal91000 DominicanRepublic.2017-02-28 變更6吸引管FEHLINGINSTRUMENTSGmbH & Co. KG國械備20170144號Hanauer Landstrae7A, 63791 Karlstein,Germany2017-02-27 有效7刮治器Hu-FriedyMfg.Co.,LLC國械備20151442號美國伊利諾斯州芝加哥市北羅克韋爾大街3232號2

4、017-02-27 變更8檢查手套Shieldtex Sdn Bhd國械備20160727號Lot 7, Jalan LadaSulah 16/11, 40000Shah Alam,Selangor DarulEhsan, Malaysia2017-02-27 變更9檢查手套Shieldtex Sdn Bhd國械備20160667號Lot 7, Jalan LadaSulah 16/11, 40000Shah Alam,Selangor DarulEhsan, Malaysia2017-02-27 變更10代型材料dentona AG國械備20170143號Otto-Hahn-Strae27.

5、 D-44227Dortmund 分地址： Am KraftwerkLippendorf. D-04575Neukieritzsch2017-02-24 有效11種植用手術(shù)導板dentona AG國械備20170142號Otto-Hahn-Strae27. D-44227Dortmund with thebranch AmKraftwerkLippendorf. D-04575Neukieritzsch2017-02-24 有效12彈性繃帶Medi GmbH & Co.KG國械備20170141號Medicusstrae 1,95448 Bayreuth,Germany2017-02-24 有

6、效13牙用手術(shù)刀Hu-Friedy Mfg. Co.,LLC國械備20161103號美國伊利諾斯州德斯普蘭斯市東凱文大街1666號 郵編60018-36072017-02-24 變更14牙科鑷DENTSPLYImplantsManufacturingGmbH國械備20161548 號Aminogatan 1, POBox 14, 43121Mlndal，SWEDEN2017-02-24 變更15牙科石膏dentona AG國械備20170140號Otto-Hahn-Strae27. D-44227Dortmund with thebranch AmKraftwerkLippendorf. D-

7、04575Neukieritzsch2017-02-24 有效16造口減壓環(huán)ConvaTec Limited國械備20151614號1405 DogwoodWay, Mebane, NC27302, USA2017-02-24 變更17牙科種植定位器DENTSPLYImplantsManufacturingGmbH國械備20161713 號Aminogatan 1, POBox 14, 43121Mlndal，SWEDEN2017-02-24 變更18螺絲起DENTSPLYImplantsManufacturingGmbH國械備20160573 號Aminogatan 1, POBox 14,

8、 43121Mlndal，SWEDEN2017-02-24 變更19轉(zhuǎn)移帽DENTSPLYImplantsManufacturingGmbH國械備20160991號Aminogatan 1, POBox 14, 43121Mlndal，SWEDEN2017-02-24 變更20牙科種植體種植工具DENTSPLYImplantsManufacturingGmbH國械備20160651 號Aminogatan 1, POBox 14, 43121Mlndal，SWEDEN2017-02-24 變更21上頜竇提升器DENTSPLYImplantsManufacturingGmbH國械備2016144

9、2號Aminogatan 1, POBox 14, 43121Mlndal，SWEDEN2017-02-24 變更22位置定位器DENTSPLYImplantsManufacturingGmbH國械備20160960號Aminogatan 1, POBox 14, 43121Mlndal，SWEDEN2017-02-24 變更23牙骨錘DENTSPLYImplantsManufacturingGmbH國械備20161441號Aminogatan 1, POBox 14, 43121Mlndal，SWEDEN2017-02-24 變更24牙用尺DENTSPLYImplantsManufactur

10、ingGmbH國械備20160570號Aminogatan 1, POBox 14, 43121Mlndal，SWEDEN2017-02-24 變更25轉(zhuǎn)移帽DENTSPLYImplantsManufacturingGmbH國械備20160649 號Aminogatan 1, POBox 14, 43121Mlndal，SWEDEN2017-02-24 變更26位置定位器DENTSPLYImplantsManufacturingGmbH國械備20161880號Aminogatan 1, POBox 14, 43121Mlndal，SWEDEN2017-02-24 變更27膝關(guān)節(jié)手術(shù)器械株式會社

11、KSI國械備20170139號1288-29,Nishisawada,Numazu-shi,Shizuoka, 410-0007,Japan2017-02-24 有效28醫(yī)用鑷EUROMEDINDUSTRIES國械備20170138號Plot No.56-A,SMALLINDUSTRIALESTATE,Sialkot,Pakistan2017-02-24 有效29持針器EUROMEDINDUSTRIES國械備20170137號Plot No.56-A,SMALLINDUSTRIALESTATE,Sialkot,Pakistan2017-02-24 有效30鞘液Luminex Corporati

12、on 國械備20160403號12212 TechnologyBlvd, Austin, Texas78727 USA2017-02-24 變更31擔架車Stryker Medical國械備20170136號3800 E. CentreAvenue PortageMichigan 49002 USA2017-02-23 有效32拉鉤MEDICON eG國械備20170135號Gnscker 15,78532 Tuttlingen,GERMANY2017-02-23 有效33骨銼MEDICON eG國械備20170134號Gnscker 15,78532 Tuttlingen,GERMANY20

13、17-02-23 有效34牙科種植體手術(shù)輔助工具Sirona DentalSystems GmbH國械備20150002號Fabrikstr.31,64625Bensheim,GERMANY2017-02-23 變更35橡皮障器械POMEE USA INC國械備20170133號MIAN ILAM DINROAD, DOBURJIARIAN SIALKOT,PUNJAB, 51310,PAKISTAN2017-02-23 有效36潔治器POMEE USA INC國械備20170132號MIAN ILAM DINROAD, DOBURJIARIAN SIALKOT,PUNJAB, 51310,P

14、AKISTAN2017-02-23 有效37口腔燈Sirona DentalSystems GmbH國械備20170131號Robert-Bosch-Strae,1,93426Roading, Germany2017-02-23 有效38醫(yī)用外固定支具THUASNE國械備20170130號118/120, rue MariusAufan BP 243 FR-92307 LEVALLOIS-PERRET; 4615Shepard St.Bakersfield, CA93313;Im Steinkamp12, 30938Burgwedel2017-02-23 有效39截骨板Stryker Leib

15、ingerGmbH & Co. KG國械備20170129號Botzinger Str. 4179111 FreiburgGermany2017-02-22 有效40口腔科手術(shù)器械Sobytek InstrumentsCo.國械備20170128號Roras road,MuzaffarPur,Sialkot 51310 -Pakistan2017-02-22 有效41拔牙鉗POMEE USA INC國械備20170127號MIAN ILAM DINROAD, DOBURJIARIAN SIALKOT,PUNJAB, 51310,PAKISTAN 2017-02-21 有效42硅橡膠復制材料VO

16、CO GmbH國械備20170126號Anton-Flettner-Str.1-3, 27472 Cuxhaven,Germany2017-02-21 有效43口腔燈 國械備20170125號(Baekseok-dong,Ilsantechnotown),1003-1,1003, 138, Ilsan-ro,Ilsandong-gu,Goyang-si, Gyeonggi-do, Korea2017-02-21 有效44染色機Intelsint S.r.l.國械備20170124號Via Rivoli, 122, I -10090 Villarbasse(TO)2017-02-21 有效45骨

17、科定位片Acumed LLC國械備20161792號5885 NW CorneliusPass RoadHillsboro, OR97124, USA；5865E. State Road 14Columbia City, IN46725 USA；530795th AvenueKenosha, WI 53144,USA；14298 169thDrive SE Monroe,WA 98272USA；684 IndustrialDrive Camp Verde,AZ 86322 USA2017-02-21 變更46椎間融合器手術(shù)工具 Medyssey Co., Ltd.國械備20170123號129

18、, Hanbang Expo-ro,Jecheon-si,Chungcheongbuk-do,27116,Republicof Korea2017-02-21 有效47打磨拋光組件株式會社國械備20170122號愛知縣春日井市鳥居松町2丁目285番地2017-02-21 有效48代型材料Dentis Co., Ltd.國械備20170121號#99, Seongseoseo-Ro, Dalseo-Gu,Daegu, Korea2017-02-21 有效49潔治器MYUNGSUNG C&MCo., LTD國械備20170120號韓國首爾市中區(qū)世忠大路1路11，信都大廈2樓（蓬萊洞1街，信都大廈）

19、2017-02-21 有效50口腔科手術(shù)器械包bredent medicalGmbH & Co. KG國械備20170119號WeienhornerStrae 2 89250Senden Germany2017-02-20 有效51研光器KerrHawe S.A.國械備20170118號Via Strecce 4 P.O.272 6934 BioggioSwitzerland2017-02-20 有效52成形片KerrHawe S.A.國械備20170117號Via Strecce 4 P.O.272 6934 BioggioSwitzerland2017-02-20 有效53研光器KerrH

20、awe S.A.國械備20170116號Via Strecce 4 P.O.272 6934 BioggioSwitzerland2017-02-20 有效54拋光杯KerrHawe S.A.國械備20170115號Via Strecce 4 P.O.272 6934 BioggioSwitzerland2017-02-20 有效55骨科保護支具BSN medical GmbH國械備20160006號Berersdorfstrasse 1,46446 Emmerich,Deutschland2017-02-20 變更56踝關(guān)節(jié)固定器BSN medical GmbH國械備20151651號Bei

21、ersdorfstrasse 1,46446 Emmerich,Deutschland2017-02-20 變更57踝關(guān)節(jié)固定器BSN medical GmbH國械備20151599號Av. Parque SN VillaFlorida, Reynosa,Tamauplipas 88715,Mexico2017-02-20 變更58眼科手術(shù)刀E.JANACH S.r.l.國械備20170114號Via Borgovico, 3522100 Como Italia2017-02-20 有效59開瞼器E.JANACH S.r.l.國械備20170113號Via Borgovico, 3522100

22、 Como Italia 2017-02-20 有效60內(nèi)耳手術(shù)剝離針Aesculap AG國械備20170112號Am Aesculap-Platz,78532 Tuttlingen,Germany 2017-02-17 有效61五官科吸引管Aesculap AG國械備20170111號Am Aesculap-Platz,78532 Tuttlingen,Germany2017-02-17 有效62骨科撐開器StarmedEngineering (Pvt)Ltd.國械備20150599號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02-1

23、7 變更63骨科復位鉗StarmedEngineering (Pvt)Ltd.國械備20150494號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02-17 變更64骨膜剝離器StarmedEngineering (Pvt)Ltd.國械備20150487號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02-17 變更65骨拉鉤StarmedEngineering (Pvt)Ltd.國械備20150600號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakista

24、n2017-02-17 變更66鼻骨銼Aesculap AG國械備20170110號Am Aesculap-Platz,78532 Tuttlingen,Germany 2017-02-17 有效67髖關(guān)節(jié)拉鉤StarmedEngineering (Pvt)Ltd.國械備20161060號191,Khadim AliRoad,Sialkot-Pakistan2017-02-17 變更68咬骨剪StarmedEngineering (Pvt)Ltd.國械備20150454號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02-17 變更69骨質(zhì)活

25、檢提取器StarmedEngineering (Pvt)Ltd.國械備20150455號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02-17 變更70鋼絲剪StarmedEngineering (Pvt)Ltd.國械備20150463號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02-17 變更71皮管鉗Aesculap AG國械備20170109號Am Aesculap-Platz,78532 Tuttlingen,Germany2017-02-17 有效72骨科吸引器Starmed

26、Engineering (Pvt)Ltd.國械備20151102號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02-17 變更73骨用牽開器StarmedEngineering (Pvt)Ltd.國械備20150388號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02-17 變更74鉤針StarmedEngineering (Pvt)Ltd.國械備20151058號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02-17 變更75骨銼S

27、tarmedEngineering (Pvt)Ltd.國械備20151140號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02-17 變更76可變神經(jīng)剝離器（子）StarmedEngineering (Pvt)Ltd.國械備20150457號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02-17 變更77骨鑿StarmedEngineering (Pvt)Ltd.國械備20150754號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02

28、-17 變更78骨錘StarmedEngineering (Pvt)Ltd.國械備20151141號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02-17 變更79骨刮匙StarmedEngineering (Pvt)Ltd.國械備20150761號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02-17 變更80咬骨鉗StarmedEngineering (Pvt)Ltd.國械備20150479號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan20

29、17-02-17 變更81研光器DENTSPLY Caulk國械備20170108號38W. Clarke AvenueMilford, DE, 19963,United States2017-02-17 有效82手動手術(shù)臺OPT SurgiSystemsS.r.l.國械備20170107號Via Cesare Battisti,17-38060CALLIANO(TN), Italy2017-02-17 有效83牙科鑷Storz am MarkGmbH國械備20170106號Emminger Strae39, 78576Emmingen-LiptingenGermany2017-02-17 有

30、效84牙科種植專用器械包 Neobiotech Co., Ltd.國械備20170105號104, 24/102, 103,104-1, 104-2, 105,106, 205, 212, 312,509, 510, 511, 10F,36, Digital-ro 27-gil,Guro-gu, Seoul,KOREA2017-02-16 有效85研光器KerrHawe S.A.國械備20170104號Via Strecce 4 P.O.272 6934 BioggioSwitzerland2017-02-16 有效86研光器KerrHawe S.A.國械備20170103號Via Strec

31、ce 4 P.O.272 6934 BioggioSwitzerland2017-02-16 有效87微創(chuàng)牽開器StarmedEngineering (Pvt)Ltd.國械備20151057號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02-16 變更88打入器StarmedEngineering (Pvt)Ltd.國械備20150762號Khadim AliRoad,P.O.BOXNO191,Sialkot-Pakistan2017-02-16 變更89血細胞分析用溶血劑株式會社國械備20160109號兵庫縣小野市匠臺17番地2017-0

32、2-16 變更90持針器Max HauserSddeutscheChirurgie-MechanikGmbH國械備20170102號德國圖特靈恩市松樹街33號，郵編785322017-02-16 有效91醫(yī)用鑷Max HauserSddeutscheChirurgie-MechanikGmbH國械備20150930號德國圖特靈恩市松樹街33號，郵編78532Föhrenstraße 33，78532 TuttlingenGermanyFoehrenstrasse 33，78532TuttlingenGermany2017-02-16 變更92軟組織環(huán)切刀ZUGA MEDI

33、CAL,INC.國械備20151683號24400 CHAGRINBLVD STE 250BEACHWOOD, OHUSA 441222017-02-15 變更93腰椎融合器手術(shù)工具bricon GmbH國械備20170101號Wasserkuppenstrasse 29-31-36043Fulda Germany2017-02-15 有效94角膜環(huán)鉆E.JANACH S.r.l.國械備20170100號Via Borgovico, 3522100 Como Italia2017-02-15 有效95鼻剪Aesculap AG國械備20170099號Am Aesculap-Platz,7853

34、2 Tuttlingen,Germany 2017-02-15 有效96鼻組織鉗Aesculap AG國械備20170098號Am Aesculap-Platz,78532 Tuttlingen,Germany2017-02-15 有效97磷酸鹽鑄造包埋材料bredent GmbH &Co. KG國械備20170097號WeienhornerStrae 2 89250Senden Germany2017-02-14 有效98牙科種植體取出工具包Neobiotech Co., Ltd.國械備20170096號104, 24/102, 103,104-1, 104-2, 105,106, 205,

35、 212, 312,509, 510, 511, 10F,36, Digital-ro 27-gil,Guro-gu, Seoul,KOREA2017-02-14 有效99核酸提取試劑GeneOhm SciencesCanada, Inc.國械備20160212號2555, Boul. du ParcTechnologique,Quebec, Quebec,G1P 4S5,Canada2017-02-14 變更100牙用刀Aesculap AG國械備20170095號Am Aesculap-Platz,78532 Tuttlingen,Germany2017-02-14 有效101胸腰段前路脊

36、柱內(nèi)固定系統(tǒng)手術(shù)器械Aesculap AG國械備20170094號Am Aesculap-Platz,78532 Tuttlingen,Germany2017-02-14 有效102醫(yī)用檢查燈Rudolf RiesterGmbH國械備20170093號Bruckstrae31，72417Jungingen,Germany2017-02-14 有效103牙科手術(shù)工具包Neobiotech Co., Ltd.國械備20170092號104, 24/102, 103,104-1, 104-2, 105,106, 205, 212, 312,509, 510, 511, 10F,36, Digital

37、-ro 27-gil,Guro-gu, Seoul,KOREA2017-02-13 有效104上頜竇提升工具包Neobiotech Co., Ltd.國械備20170091號104, 24/102, 103,104-1, 104-2, 105,106, 205, 212, 312,509, 510, 511, 10F,36, Digital-ro 27-gil,Guro-gu, Seoul,KOREA2017-02-13 有效105耳刮匙Advanced BionicsAG 國械備20170090號28515WestinghousePlace, Valencia CA91355,USA; 12

38、740San Fernando Road,Sylmar CA 91342,USA2017-02-13 有效106外耳道擴張器Advanced BionicsAG 國械備20170089號28515WestinghousePlace, Valencia CA91355,USA; 12740San Fernando Road,Sylmar CA 91342,USA2017-02-13 有效107顯微鉤Advanced BionicsAG 國械備20170088號28515WestinghousePlace, Valencia CA91355,USA; 12740San Fernando Road,

39、Sylmar CA 91342,USA 2017-02-13 有效108乳突器械敲擊錘Advanced BionicsAG 國械備20170087號28515WestinghousePlace, Valencia CA91355,USA; 12740San Fernando Road,Sylmar CA 91342,USA2017-02-13 有效109醫(yī)用放大鏡ION VISION, INC.國械備20170086號40W548 SettlementDr Campton Hills ,IL USA 601752017-02-13 有效110熱敏打印機株式會社國械備20170085號靜岡縣湖西

40、市境宿2017-02-13 有效111手術(shù)頭架Medprin BiotechGmbH國械備20170084號Gutleutstrae 163-167, 60327 Frankfurtam Main, Germany2017-02-13 有效112轉(zhuǎn)移帽ZUGA MEDICAL,INC.國械備20160963號 24400 CHAGRINBLVD STE 250BEACHWOOD, OHUSA 441222017-02-10 變更113螺絲起ZUGA MEDICAL,INC.國械備20151684號24400 CHAGRINBLVD STE 250BEACHWOOD, OHUSA 4412220

41、17-02-10 變更114手術(shù)頭架Herbert（Thailand）Co., Ltd.國械備20170083號47 Moo 1 MitraphapRoad, TambonSamran, AmphurMuang, Khon Kaen40000, Thailand2017-02-10 有效115轉(zhuǎn)移圈ZUGA MEDICAL,INC.國械備20160946號24400 Chagrin BlvdSte 250 Beachwood,OH 441222017-02-09 變更116扭力扳手ZUGA MEDICAL,INC.國械備20140173號1163 E 40th St Ste202 Clevel

42、and, OHUSA 441142017-02-09 變更117種植體掃描體 ZUGA MEDICAL,INC. 國械備20151682號 24400 CHAGRINBLVD STE 250BEACHWOOD, OHUSA 441222017-02-09 變更118牙科種植定位器 ZUGA MEDICAL,INC國械備20160964號24400 Chagrin BlvdSte 250 Beachwood,OH 441222017-02-09 變更119轉(zhuǎn)移帽Neobiotech Co., Ltd.國械備20170082號104, 24/102, 103,104-1, 104-2, 105,1

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