NMPA registration information for imported Class I medical devices in July 2024

No.Product NameName of the filing personProduction addressFiling dateStatus
1ScrewdriverNeobiotech Co., Ltd.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, KOREA2024-07-31Change
2Sinus Lift KitNeobiotech Co., Ltd.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, KOREA2024-07-31Change
3Dental surgery kitsNeobiotech Co., Ltd.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, KOREA2024-07-31Change
4Implant ScannerNeobiotech Co., Ltd.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, KOREA2024-07-31Change
5 Rubber DamSANCTUARY HEALTH SDN BHDNo.16, Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan, 31200 Chemor, Perak, Malaysia2024-07-31Change
6Light-curing gum barrier resinSANCTUARY HEALTH SDN. BHD.No.16, Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan, 31200 Chemor, Perak, Malaysia.2024-07-31Change
7Rubber Dam Equipment KitSANCTUARY HEALTH SDN BHD57, Hwanggeum-ro, 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do, Korea2024-07-31Change
8Automatic electrophoresis instrument株式会社ヘレナ研究所9-21-19 Tokiwa, Urawa-ku, Saitama-shi, Saitama 330-0061 JAPAN2024-07-30Change
9Sample diluentRoche Diagnostics GmbHSandhofer Strasse 116, 68305 Mannheim,Germany2024-07-30Change
10 DAPI staining solutionKreatech Biotechnology B.V.Vlierweg 20, 1032 LG Amsterdam, The Netherlands2024-07-30Valid
11DAPI staining solutionKreatech Biotechnology B.V.Vlierweg 20, 1032 LG Amsterdam, The Netherlands2024-07-30Valid
12Platelet OscillatorHelmer Inc.14400 Bergen Boulevard Noblesville, IN 46060 USA2024-07-29Change
13Oral isolation device(주)신흥42-25, Dongsan-Ro 27beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Korea Rep.2024-07-29Change
14Spat hook株式会社デンテック東京都板橋区清水町53-52024-07-26Valid
15Acupoint pressure stimulation patch(주)아텍스경기도 파주시 광탄면 장지산로 146 M 동 3 층2024-07-26Valid
16Dental polishing headUltradent Products, Inc.Neureutstr.6, 75210 Keltern, Germany2024-07-25Valid
17Dental implant surgery toolsEvidence implant Inc.32,Innovalley-ro, Dong-gu, Daegu, 41065, Republic of Korea2024-07-25Valid
18Ear drilling positioning kitMED-EL Elektromedizinische Geräte GmbHFürstenweg 77A 6020 Innsbruck AUSTRIA2024-07-25Valid
19Tissue dehydratorMilestone S.r.l.Via Fatebenefratelli, 1/5 24010 SORISOLE (BG) Corso Europa Unita, 6 IT – 24030 VALBREMBO (BG)2024-07-25Change
20Wash Buffer VKreatech Biotechnology B.V.Vlierweg 20, 1032 LG Amsterdam, The Netherlands2024-07-25Change
21Pretreatment Buffer BKreatech Biotechnology B.V.Vlierweg 20, 1032 LG Amsterdam, The Netherlands2024-07-25Change
22FOXO1 (13q14) gene break probe reagent (fluorescence in situ hybridization)Kreatech Biotechnology B.V. Vlierweg 20, 1032 LG Amsterdam, The Netherlands2024-07-25Change
23EGFR (7p11) / SE7 (D7Z1) gene amplification probe reagent (fluorescence in situ hybridization method)Kreatech Biotechnology B.V. Vlierweg 20, 1032 LG Amsterdam, The Netherlands2024-07-25Change
24BCL2 (18q21) Gene Break Probe Reagent (Fluorescence in situ hybridization)Kreatech Biotechnology B.V.Vlierweg 20, 1032 LG Amsterdam, The Netherlands2024-07-25Change
25TOP2A gene amplification probe reagent (in situ hybridization method)//2024-07-25Change
26Microwave tissue dehydratorMilestone S.r.l.Via Fatebenefratelli, 1/5IT-24010 Sorisole (BG) Corso Europa,6 IT-24030 Valbrembo (BG)2024-07-25Change
27Ki-67 Antibody ReagentsLeica Biosystems Newcastle LtdBalliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom2024-07-25Valid
28Ki-67 Antibody ReagentsLeica Biosystems Newcastle LtdBalliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom2024-07-25Valid
29Immunochromogenic reagentsLeica Biosystems Newcastle LtdBalliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2024-07-25Change
30FixerJulius Zorn GmbH见附件2024-07-24Change
31Pressure bandageJulius Zorn GmbH见附件2024-07-24Change
32AE1/AE3 mixed molecular weight keratin antibody reagentLeica Biosystems Newcastle LtdBalliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom2024-07-24Valid
33AMACR Antibody ReagentsLeica Biosystems Newcastle LtdBalliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom2024-07-24Valid
34Pressure bandageJulius Zorn GmbH见附件2024-07-24Change
35Pressure bandageSIGVARIS AGGröblistrasse 8,CH-9014 St. Gallen,Switzerland2024-07-24Change
36Dental LightFARO SPAVIA FARO 15-20876 ORNAGO (MB)2024-07-24Change
37Dental Instrument PliersBioclear Matrix Systems, LLC3802 S Warner Street Suite A Tacoma, WA US 984092024-07-23Change
38Dental Forming Plate SetBioclear Matrix Systems, LLC3802 S Warner Street Suite A Tacoma, WA US 984092024-07-23Change
39Dental Forming Plate SetBioclear Matrix Systems, LLC3802 S Warner Street Suite A Tacoma, WA US 984092024-07-23Change
40Dental Forming Plate SetBioclear Matrix Systems, LLC3802 S Warner Street Suite A Tacoma, WA US 984092024-07-23Change
41Intraoral shaping knife setBioclear Matrix Systems, LLC3802 S Warner Street Suite A Tacoma, WA US 984092024-07-23Change
42Dental measuring rodBioclear Matrix Systems, LLC3802 S Warner Street Suite A Tacoma, WA US 984092024-07-23Change
43Dental measuring rodBioclear Matrix Systems, LLC3802 S Warner Street Suite A Tacoma, WA US 984092024-07-23Change
44Dental Instrument PliersBioclear Matrix Systems, LLC3802 S Warner Street Suite A Tacoma, WA US 984092024-07-23Change
45Dental forcepsBioclear Matrix Systems, LLC3802 S Warner Street Suite A Tacoma, WA US 984092024-07-23Change
46Dental Forming Plate SetBioclear Matrix Systems, LLC3802 S Warner Street Suite A Tacoma, WA US 984092024-07-23Change
47Forming clipBioclear Matrix Systems, LLC3802 S Warner Street Suite A Tacoma, WA US 984092024-07-23Change
48Forming sheetBioclear Matrix Systems, LLC3802 S Warner Street Suite A Tacoma, WA US 984092024-07-23Change
49Dental surgery instrumentsSLOKI SURGICALSublime Chowk,Wazirabad Road,Gujjar Town,Sialkot-Pakistan2024-07-23Valid
50Implant surgery kitZimmer Dental, Inc.1900 Aston Avenue, Carlsbad, CA 92008, USA2024-07-23Change
51Cleaning fluidMedica Corporation5 Oak Park Drive, Bedford, Massachusetts 01730 USA2024-07-22Change
52Urinalysis diluentMedica Corporation5 Oak Park Drive, Bedford, Massachusetts, 01730, United States2024-07-22Change
53Sample diluent日本電子株式会社茨城県龍ヶ崎市向陽台三丁目3番1号 3-1, Koyodai 3-chome, Ryugasaki-shi, Ibaraki 301-0852 Japan2024-07-22Change
54 Dental RulerAlpha-Bio Tec Ltd7 Hatnufa St., Kiryat Arye, POB 3936 Petach Tikva, 4951025 Israel2024-07-22Change
55TERC gene amplification probe reagent (in situ hybridization method)//2024-07-19Change
56WT1 (11p13) gene break probe reagent (fluorescence in situ hybridization)ZytoVision GmbHFischkai 1, 27572 Bremerhaven, Deutschland2024-07-19Valid
57Dental surgery instrumentsNIBBLE SURGICALAbyala,P/O Box Dholo Bhelo,Sialkot-Pakistan2024-07-19Valid
58Needle-free injection pusher呈汝生物科技股份有限公司高雄市左營區大順一路91號5樓之62024-07-18Change
59Bullet-type light-curing resin delivery deviceUltradent Products, Inc.770 River Road, Shelton, CT 06484, USA2024-07-17Valid
60Elastic strap for fixing Bauerfeind AGTriebeser Straße 16 07937 Zeulenroda-Triebes Germany2024-07-17Change
61Androgen Receptor (AR) Antibody ReagentsCell Marque Corporation6600 Sierra College Blvd. Rocklin CA 95677 USA2024-07-17Valid
62p40 antibody reagentVentana Medical Systems, Inc.1910 East Innovation Park Drive, Tucson AZ 85755, USA2024-07-17Valid
63 Podoplanin Antibody ReagentsCell Marque Corporation6600 Sierra College Blvd. Rocklin CA 95677 USA2024-07-17Valid
64Specific AT sequence binding protein 2 (SATB2) antibody reagentCell Marque Corporation6600 Sierra College Blvd. Rocklin CA 95677 USA2024-07-17Valid
65Transfer CapAlpha-Bio Tec Ltd.7 Hatnufa St.,Kiryat Arye,POB 3936 Petach Tikva,4951025,Israel2024-07-17Change
66Body positioning bagMEDTEC,Inc.1401 8th St.SE,Orange City,IA,51041,United States2024-07-17invalid
67Medical image printerAgfa NVMax-Planck-Str. 1, 82380, Peiβenberg, Germany2024-07-16Change
68Ultrasonic dental scaler tipsE.M.S. Electro Medical Systems S.A.Rte. de Champ-Colin 2, 1260 Nyon, Switzerland2024-07-16Change
69Saliva suction tubeE.M.S. Electro Medical Systems S.A.Rte. de Champ-Colin 2, 1260 Nyon, Switzerland2024-07-16Change
70Plaque indicatorProduits Dentaires SA18 rue des Bosquets CH-1800 Vevey2024-07-15invalid
71Band-AidYoung Chemical Co., Ltd.80-93, Golden root-ro, Juchon-myeon, Gimhae-si, Gyeongsangnam-do, 50969, Republic of Korea2024-07-15Valid
72Clip Applier (without clip)PETERS SURGICAL见附件22024-07-12Change
73Blood collection pen华广生技股份有限公司大庆厂台中市南区大庆街二段100号2024-07-12Change
74Elastic bandageCIZETA MEDICALI S.P.A.Via IV Novembre,46-20012 CUGGIONO(MI)-ITALY2024-07-11Change
75Radiotherapy positioning deviceAnatomical Geometry, S.L.C/ FORMACIÓN, Nº 6 (NAVE), PARQUE INDUSTRIAL Y DE SERVICIOS ALJARAFE, 41927 MAIRENA DEL ALJARAFE – SEVILLA (ESPAÑA)2024-07-11Valid
76Mobile slide padArjoHuntleigh ABul.ks.Wawrzyniaka 2, 62-052 Komorniki, Poland2024-07-11Valid
77Medical examination glovesGLOMAXES LATEX GLOVE MANUFACTURER SDN.BHD.No.153,Jalan 4,Kawasan Perindustrian Olak Lempit,42700 Banting,Selangor Darul Ehsan,Malaysia.2024-07-11Change
78Disposable medical nitrile rubber glovesGLOMAXES LATEX GLOVE MANUFACTURER SDN.BHD.No.153,Jalan 4,Kawasan Perindustrian Olak Lempit,42700 Banting,Selangor Darul Ehsan,Malaysia.2024-07-11Change
79Medical examination glovesGLOMAXES LATEX GLOVE MANUFACTURER SDN.BHD.No.153,Jalan 4,Kawasan Perindustrian Olak Lempit,42700 Banting,Selangor Darul Ehsan,Malaysia.2024-07-11Change
80Metal double-wing vaginal dilatorSHENDU PAKStreet No.4, Khan Mahal Road, Ahmadpura Sialkot-51310-Pakistan2024-07-11Valid
81Oral digital viewing instrumentModJaw SAS354 Voie Magellan 73800 Sainte-Hélène-du-Lac France2024-07-10Change
82Enhancement fluidBioledomics, Inc.6 Davis Drive Durham,NC USA 277092024-07-10invalid
83Dental implant instruments and toolsDENTIS Co., Ltd.99, Seongseoseo-ro, Dalseo-gu, Daegu, Republic of Korea / 1F, B-dong, 6, Yulam-ro, Dong-gu, Daegu, Republic of Korea2024-07-09Valid
84Ligating forcepsTeleflex Medical5307 95th Avenue, Kenosha, WI 53144, USA2024-07-09Change
85Diagnostic aidsWELDON INSTRUMENTSGanjay Wali street Rai Pur Stop, Wazirabad Road, Sialkot, 51310, Pakistan2024-07-08Valid
86Electric shift carLINET spol. s r.o.Želevčice 5, 274 01 Slaný, CZECH REPUBLIC2024-07-08Valid
87Orthopedic screwdriverLEADER MEDICA S.r.l.Via dell’Industria, 13-IT 35030 Bastia di Rovolon (PD)2024-07-05Valid
88Dental material mixing injection headSuno Biotechnology Co., LTD5th Floor, No.4, 207, Xinshu Road, Xinzhuang District, New Taipei City, Taiwan2024-07-04Valid
89 Abrasive materialsDENTAL TECHNOLOGIES,INC.6901 North Hamlin Ave. Lincolnwood , IL USA 607122024-07-04Change
90Medical examination glovesLIENTEH TECHNOLOGY SDN. BHD.LOT 6483 JALAN SUNGAI PULOH, KU5, KAWASAN PERINDUSTRIAN SUNGAI PULOH, 42100 KLANG, SELANGOR, MALAYSIA2024-07-04Valid
91Ostomy bagConvaTec Inc.Carretera Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic.2024-07-04Change
92Medical examination glovesJoleda Sdn.Bhd.42A-1, Jalan Equine 1G,Pusat Komersil Equine,Taman Equine,43300 Seri Kembangan,Selangor Darul Ehsan,Malaysia2024-07-02Valid
93Silk cloth tape3M Health Care3M Brookings, 601 22ND AVE. South Brookings, South Dakota, 57006, USA2024-07-02invalid
94Silicone pressure sensitive tape3M Company, 3M Health Care610 North County Rd.19, Aberdeen, South Dakota, 57401, USA2024-07-02invalid
95Fiberglass Bandage3M Company, 3M Health Care5500 Ooaza-Osanagi,Higashine-shi,Yamagata 999-3737 Japan2024-07-02invalid
96Plaster pads3M Company, 3M Health CareMarialoopsteenweg 51 8760 Meulebeke (Tielt), Belgium2024-07-02invalid
97Drill depth stopAlpha-Bio Tec. Ltd.7 Hatnufa St., Kiryat Arye, POB 3936, Petach-TiKva, 4951025, Irsael2024-07-02Change
98Dental soft tissue cutterAlpha-Bio Tec Ltd.7 Hatnufa St., Kiryat Arye, POB 3936 Petach Tikva, 4951025 Israel2024-07-02Change
99ScrewdriverAlpha-Bio Tec Ltd.7 Hatnufa St., Kiryat Arye, POB3936, Petach Tikva, 4951025 Israel2024-07-02Change
100Immobilization devices for patients undergoing radiation therapyMEDTEC LLC1401 8th St. SE, Orange City, IA, 51041, United States2024-07-02Change
101Cranial radiotherapy positioning deviceMEDTEC LLC1401 8th St. SE, Orange City, IA, 51041, United States2024-07-02Change
102Immobilization devices for patients undergoing radiation therapyMEDTEC LLC1401 8th St.SE,Orange City,IA,51041,United States2024-07-02Change
103Immobilization devices for patients undergoing radiation therapyMEDTEC LLC1401 8th St.SE,Orange City,IA,51041,United States2024-07-02Change
104Immobilization devices for patients undergoing radiation therapyMEDTEC LLC1401 8th St. SE, Orange City, IA, 51041, United States2024-07-02Change
105Radiotherapy positioning deviceMEDTEC LLC1401 8th St. SE, Orange City, IA, 51041, United States2024-07-02Change
106Immobilization devices for patients undergoing radiation therapyMEDTEC LLC1401 8TH ST. S.E. Orange City, IA USA 510412024-07-02Change
107Immobilization devices for patients undergoing radiation therapyMEDTEC LLC1401 8th St.SE,Orange City,IA,51041,United States2024-07-02Change
108Ultrasound probe puncture holderCIVCO Medical Instruments Co.,Inc.102 FIRST ST.SOUTH Kalona, IA USA 522472024-07-02Change
109Dental Model Materialsdelcone inc.428-8, Waryong-ro, Seo-gu, Daegu, Republic of Korea2024-07-01Change
110Articulating PaperParkell  Inc.300 Executive Drive, Edgewood, NY, 11717, United States2024-07-01Change
111Orthopedic surgical instrumentsHAQ SURGICAL(PVT)LTDMuhallah Loharan Wala Khou, Muzaffar Pur, Near Roras Road, Sialkot – Pakistan2024-07-01Valid
112Peritoneal dialysis line clampBaxter Healthcare SAFoxford Road, Swinford, CO.Mayo, IRELAND2024-07-01Change
113Fungal fluorescent staining solutionBioMedomics, Inc.6 Davis Drive Durham, NC USA 277092024-07-10invalid