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2023年11月進口第一類醫(yī)療器械產品備案信息
發(fā)布日期:2023-12-06 17:36瀏覽次數:3522次
2023年12月06日，國家藥監(jiān)局發(fā)布《2023年11月進口第一類醫(yī)療器械產品備案信息》，2023年11月累計批準180個進口第一類醫(yī)療器械產品備案產品。

2023年12月06日，國家藥監(jiān)局發(fā)布《2023年11月進口第一類醫(yī)療器械產品備案信息》，2023年11月累計批準180個進口第一類醫(yī)療器械產品備案產品。

進口第一類醫(yī)療器械產品備案.jpg

2023年11月進口第一類醫(yī)療器械產品備案信息

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(tài)
1膝關節(jié)手術工具國械備20210189號DePuy   Ireland UC請見附件“生產地址”。2023-11-30 變更
2肩關節(jié)全肩肩盂側工具國械備20230564號DePuy   Orthopaedics, Inc.8   Matchett Drive, Pierceton, Indiana 46562, USA;   6688 Dixie Hwy., Bridgeport, Michigan   48722, USA;2023-11-30 有效
3動力系統配套工具國械備20210630號 Synthes GmbHEimattstrasse   3, 4436 Oberdorf, Switzerland2023-11-30 變更
4肩關節(jié)手術工具國械備20230563號Biomet   Orthopedics56   East Bell Drive, P.O. Box 587,Warsaw, Indiana 46581,USA2023-11-30 有效
5樣本稀釋液國械備20150458號Medirox   ABStudsvik,   611 82 NYK?PING, Sweden2023-11-30 變更
6基礎外科手術器械國械備20230562號SURGICAL   SOURCES INDUSTRIESUgoki   Darbar Road, Near Zoom Petrol Filling Station, Sialkot - Pakistan2023-11-30 有效
7基礎外科手術器械國械備20230561號Sehgal's   InstrumentsGhumman   St. Daska Road Pakki Kotli 51340 Sialkot Pakistan.2023-11-30 有效
8瓣膜成形環(huán)測環(huán)器及組件國械備20160017號Corcym   S.r.l.Via   Crescentino sn 13040 SALUGGIA (VC) ITALY2023-11-30 變更
9牙科種植掃描體國械備20200085號Zirkonzahn   SrlZona   Industriale Molini di Tures 3 39032 Campo Tures (BZ), Italy2023-11-30 變更
10醫(yī)用嬰兒床國械備20191436號Advanced   Healthcare Technology Ltd.Northern   Road Sudbury Suffolk CO10 2ZB UK2023-11-30 變更
11剝離器國械備20152132號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-29 變更
12PD-1（CD279）檢測試劑（流式細胞儀法)國械備20230560號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-11-28 有效
13CD9抗體試劑（流式細胞儀法）國械備20230559號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-11-28 有效
14CD41檢測試劑（流式細胞儀法）國械備20230558號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-11-28 有效
15造口皮膚保護劑國械備20191366號ConvaTec   LimitedUNIT   22, VALLEY ROAD BUSINESS PARK, BIDSTON, WIRRAL, MERSEYSIDE. CH41 7EL, UNITED   KINGDOM2023-11-28 變更
16顯微剪國械備20161108號ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 無效
17鼻剪國械備20180399號ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 無效
18扁桃體剪國械備20180397號ANTON   HIPP GmbH Annastr.25/1,78567   Fridingen,Germany2023-11-28 無效
19石膏剪國械備20180394號ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 無效
20組織剪國械備20180395號ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 無效
21鋼絲剪國械備20180299號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
22顯微鉤國械備20180495號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
23探針國械備20180499號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
24手術刀國械備20180498號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
25骨刮匙國械備20180565號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
26顯微剪國械備20180396號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
27骨膜剝離器 國械備20180563號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
28顯微剝離器國械備20161109號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
29椎板牽開器國械備20180496號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
30顯微沖洗吸引管國械備20161155號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
31 冷凍切片機  國械備20161064號 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 變更
32 冷凍切片機 國械備20150367號Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 變更
33冷凍切片機 國械備20161067號Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 變更
34冷凍切片機 國械備20180127號 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19, 69226 Nussloch, Germany2023-11-28 變更
35冷凍切片機國械備20161066號 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 變更
36染色機國械備20171212號Leica   Biosystems Nussloch GmbH1750A   Costner Drive Warrington, PA189762023-11-28 變更
37染色機 國械備20151853號 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 變更
38真空墊國械備20230557號Qfix 440   Church Road Avondale Pennsylvania 19311 USA2023-11-28 有效
39顯微針國械備20180564號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
40定位膜國械備20230556號Qfix440   Church Road Avondale Pennsylvania 19311 USA2023-11-28 有效
41口腔科手術器械國械備20230555號Sehgal's   InstrumentsGhumman   St. Daska Road Pakki Kotli 51340 Sialkot Pakistan.2023-11-27 有效
42輸氧面罩國械備20210258號新廣業(yè)股份有限公司臺中市神岡區(qū)社口里中山路312號2023-11-27 變更
43關節(jié)假體夾持器國械備20152021號 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-11-27 變更
44牙科吸潮紙尖國械備20230554號C?ng   ty TNHH Gapadent Vi?t NamL?   B-B4 C?m c?ng nghi?p Hà Lam - Ch? ???c, x? Bình Ph?c, huy?n Th?ng Bình, t?nh   Qu?ng Nam, Vi?t Nam2023-11-27 有效
45眼科植入物及輔助器械國械備20230553號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
46眼用沖吸器及手柄國械備20230552號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
47眼科用鏟國械備20230551號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
48眼用碎核器國械備20230550號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
49眼用碎核器國械備20230549號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
50角膜標記環(huán)國械備20230548號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
51角膜標記環(huán)國械備20230546號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
52 鉆石手術刀國械備20230545號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
53眼用鑷國械備20220542號KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-11-27 變更
54鉆石手術刀國械備20230544號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
55拋光清潔器具國械備20230543號W&H   Dentalwerk Bürmoos GmbHCarl-Zeiss-Strasse   16, 77656 Offenburg, Germany2023-11-27 有效
56全自動血沉分析儀國械備20230541號ALIFAX   S.r.l.Via   Merano 30 33045 Nimis (UD) Italy2023-11-24 有效
57醫(yī)學圖像體外定位貼國械備20230540號Zimmer   CAS75   Queen Street, Suite 3300, Montreal, Quebec H3C 2N6, Canada2023-11-24 有效
58頭燈國械備20160035號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
59醫(yī)用檢查音叉國械備20171244號RZ   Medizintechnik GmnHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 變更
60手外科固定復位鑷國械備20171154號RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 變更
61顯微剪國械備20170856號RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 變更
62顯微持針鑷國械備20170855號RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 變更
63顯微止血夾國械備20170848號RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 變更
64顯微鑷國械備20170009號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
65吸引管國械備20160141號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
66口腔開口器國械備20160034號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
67鉤針國械備20160033號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
68骨錘國械備20160030號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
69探針國械備20160028號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
70手術刀國械備20152117號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
71外科牽開器國械備20152120號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
72 支撐喉鏡國械備20180222號RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany 2023-11-23 變更
73醫(yī)用鑷國械備20152116號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
74骨銼國械備20152119號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
75鼻窺器國械備20152118號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
76骨鑿 國械備20152131號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
77刮匙國械備20151685號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
78醫(yī)用剪國械備20151641號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
79止血鉗 國械備20151642號RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2023-11-23 變更
80組織鉗國械備20150692號RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2023-11-23 變更
81持針鉗國械備20150693號RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2023-11-23 變更
82咬骨鉗國械備20150690號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
83口腔科手術器械國械備20230539號SURGICAL   SOURCES INDUSTRIESUgoki   Darbar Road, Near Zoom Petrol Filling Station, Sialkot - Pakistan2023-11-23 有效
84顱骨牽引器國械備20180497號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-23 無效
85顯微鑷國械備20161111號ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-23 無效
86咬骨鉗國械備20161156號ANTON   HIPP GmbH Annastr.25/1,78567   Fridingen,Germany2023-11-23 無效
87紗布繃帶剪國械備20180298號ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-23 無效
88顯微持針鉗國械備20161110號ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-23 無效
89耳鼻喉科手術器械包國械備20170904號Integra   LifeSciences Production Corporation/2023-11-23 變更
90夾持鉗國械備20210024號グンゼ株式會社京都府綾部市青野町棗ヶ市462023-11-22 無效
91聚左旋乳酸可吸收骨固定系統配套工具國械備20181627號グンゼ株式會社京都府綾部市青野町棗ヶ市462023-11-22 無效
92牙科種植手術工具國械備20170168號Institut   Straumann AGPeter   Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613   Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA2023-11-21 變更
93創(chuàng)傷外科手術器械包國械備20220635號Synthes   GmbH詳見附件2023-11-20 變更
94骨科手術器械國械備20200275號Synthes   GmbH見附件。2023-11-20 變更
95醫(yī)用檢查手套國械備20230538號Sri   Trang Gloves (Thailand) Public Company Limited110/19   Ban Khao Mai Daeng, Moo 7, Phlai Wat, Kanchanadit, Surat Thani 84160,   THAILAND2023-11-20 有效
96醫(yī)用檢查手套國械備20230537號Sri   Trang Gloves (Thailand) Public Company Limited110/19   Ban Khao Mai Daeng, Moo 7, Phlai Wat, Kanchanadit, Surat Thani 84160,   THAILAND2023-11-20 有效
97牙科手術器械包國械備20230536號MIHHA   ENTERPRISESNizam   Street, Kotli Behram, Sialkot-Pakistan2023-11-20 有效
98醫(yī)用檢查手套國械備20170895號Sri   Trang Gloves (Thailand) Public Company Limited110   Kanjanavanit Road, Pahtong, Hatyai, Songkhla 90230, Thailand2023-11-20 變更
99橡皮障夾鉗國械備20191288號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-17 變更
100醫(yī)用退熱貼 國械備20171169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2023-11-16 變更
101拔牙鉗國械備20191261號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
102牙科剪國械備20191259號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
103阻生齒牙挺國械備20191264號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
104牙探針國械備20191285號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
105口腔麻醉劑手動助推器國械備20191345號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
106牙骨膜分離器國械備20191265號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
107橡皮膏 國械備20151099號Lohmann   & Rauscher International GmbH & Co.KGWesterwaldstraβe   4,56579 Rengsdorf GERMANY2023-11-16 無效
108頸部固定器國械備20170969號Ottobock   SE & Co. KGaAMax   N?derStra?e 15 37115 Duderstadt,Germany2023-11-16 變更
109位置定位器國械備20160638號Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 變更
110牙用尺國械備20160637號Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 變更
111轉移帽國械備20160639號Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 變更
112螺絲起國械備20160640號Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 變更
113牙科種植定位器國械備20160653號Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 變更
114轉移帽國械備20161044號Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 變更
115代型材料國械備20170121號Dentis   Co., Ltd.#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 變更
116口鏡國械備20191279號COMMIC   SURGICO羅拉絲路，諾切區(qū)，錫亞爾科特市，郵編51310，巴基斯坦2023-11-16 變更
117牙用充填器國械備20191260號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
118橡皮障夾國械備20191291號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
119牙用鑷國械備20191263號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
120成形片夾國械備20191262號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
121牙科器械鉗國械備20191258號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
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124扭力扳手國械備20230257號????   ????????   ??? ?????4? 23-32023-11-15 變更
125足托固定器國械備20161906號Ottobock   SE & Co. KGaAMax-N?der-Stra?e   15, 37115 Duderstadt, Germany2023-11-15 變更
126肩關節(jié)固定器國械備20171259號Ottobock   SE & Co. KGaAMax   N?derStra?e 15 37115 Duderstadt,Germany2023-11-15 變更
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128一件式造口袋國械備20200123號ConvaTec   LimitedCarretera   Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic.2023-11-15 變更
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132清洗液   Artisan 50x Wash Solution國械備20150166號Agilent   Technologies, Inc.6392   Via Real Carpinteria, CA 930132023-11-14 變更
133創(chuàng)口貼國械備20230532號Beiersdorf   AGCtra.de   Mataró a Granollers P .Km 5,6,08310 Argentona (Barcelona) ,Spanien2023-11-14 有效
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137引流袋系統國械備20230528號怡安醫(yī)療器材股份有限公司臺灣省臺中市梧棲區(qū)經三路39號2023-11-14 有效
138全自動核酸提取純化儀國械備20230527號Promega   Corporation1017,   A Building Gangseo-Hangang-Xi Tower 401, Yangcheon-ro Gangseo-gu Seoul 07528   Republic of Korea2023-11-14 有效
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145牙科成形片套裝國械備20230524號AFRZ   CORPORATIONRoras   Road, Near Makki Masjid, Sialkot - Pakistan2023-11-09 有效
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147血細胞分析用稀釋液國械備20230522號シスメックス株式會社17   Takumidai, Ono, Hyogo 675-1322, Japan2023-11-09 有效
148血細胞分析用溶血劑國械備20230521號シスメックス株式會社17   Takumidai, Ono, Hyogo 675-1322, Japan2023-11-09 有效
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152漏斗胸手術器械包國械備20161051號Biomet   Microfixation見附件2023-11-08 變更
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158樣本萃取液及流動相溶劑包(串聯質譜法)國械備20140120號Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-11-07 變更
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166腰部固定器國械備20190176號?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-11-06 變更
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169高速離心機國械備20180864號Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany;       175 Freshwater Boulevard, Enfield CT 06082, USA2023-11-03 變更
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171套管國械備20200001號Medtronic   Powered Surgical Solutions4620   North Beach Street Fort Worth Texas 76137 USA2023-11-02 變更
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