Class I imported medical devices registration information in June 2024

The class I imported medical devices registration information in June 2024 is as follows:

No.Product nameFilling NameProduction addressFiling dateStatus
1Planting aidsMIS Implants Technologies Ltd.Bar Lev Industrial Park, 2015600, Israel 2024-06-28change
2Implant Installation Aid KitMIS Implants Technologies Ltd. PO Box 7 Bar Lev Industrial Park, 2015600, Israel 2024-06-28change
3Elastic sleeveSigvaris do Brasil Indústria e Comércio Ltda.Av. José Benassi, 2323 Distrito Industrial Fazgran Jundiaí São Paulo 13213085 Brasil. 2024-06-28change
4Dental polishing discEVE Ernst Vetter GmbHNeureutstr.6, 75210 Keltern, Germany 2024-06-27efficient
5Lumbar fixatorAspen Medical Products, Inc.6481 Oak Canyon Irvine,CA 92618 2024-06-27change
6Thoracolumbar fixatorAspen Medical Products, Inc.6481 Oak Canyon Irvine,CA 92618 2024-06-27change
7Cervical fixatorAspen Medical Products, Inc.6481 Oak Canyon Irvine,CA 92618 2024-06-27change
8Knee surgery toolsWaldemar Link GmbH & Co. KGBarkhausenweg 10 22339 Hamburg Germany 2024-06-27change
9OsteotomeWaldemar Link GmbH & Co.KGBarkhausenweg 10 22339 Hamburg
 GERMANY
 2024-06-27change
10Acetabular reamerWaldemar Link GmbH & Co.KGBarkhausenweg 10 22339 Hamburg GERMANY 2024-06-26change
11Medullary cavity reamerWaldemar Link GmbH & Co.KGBarkhausenweg 10 22339 Hamburg GERMANY 2024-06-26change
12Bone Placement DeviceAB Dental Devices Ltd19 Hayahalomim Street Ashdod 7761117 Israel 2024-06-26change
13Implant aidsAB Dental Devices Ltd.19 Hayahalomim Street Ashdod 7761117 Israel 2024-06-26change
14Dental Implant PositionerAB Dental Devices Ltd.19 Hayahalomim Street Ashdod 7761117 Israel 2024-06-26change
15Torque wrenchAB Dental Devices Ltd.19 Hayahalomim Street Ashdod 77609 Israel 2024-06-26change
16Planting aidsAB Dental Devices Ltd.19 Hayahalomim Street Ashdod 7761117 Israel 2024-06-26change
17Dental Implant ScannerABDental Devices Ltd.19 Hayahalomim Street Ashdod 7761117 Israel 2024-06-26change
18ScrewdriverAB Dental Devices Ltd.19 Hayahalomim Street Ashdod 77611179 Israel 2024-06-26change
19Plastic cylinder OSSTEM IMPLANT Co., Ltd.66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea 2024-06-26change
20Dental LightG. COMM Sr l.VIA DONIZETTI 22 I-20872 CORNATE D’ADDA(MB) 2024-06-26change
twenty oneDental LightG. COMM Sr l.VIA DONIZETTI 22 I-20872 CORNATE D’ADDA(MB) 2024-06-26change
twenty twoOrthodontic pliersOrtho Organizers, Inc.1.Ranger HQ Road Cantt, Sialkot – Pakistan; 2.3232 N. Rockwell Street, Chicago, IL, 60618, United States; 3.Nasir Road, Sialkot-Pakistan 2024-06-26change
twenty threeNeurological and Cardiovascular Surgery DevicesWELDON INSTRUMENTSGanjay Wali street Rai Pur Stop, Wazirabad Road, Sialkot, 51310, Pakistan 2024-06-25efficient
twenty fourSample diluentSiemens Healthcare Diagnostics Products GmbHEmil-von-Behring-Str. 76, 35041 Marburg, Germany 2024-06-25efficient
25Ophthalmic surgical instrumentsWELDON INSTRUMENTSGanjay Wali street Rai Pur Stop, Wazirabad Road, Sialkot, 51310, Pakistan 2024-06-25efficient
26ENT surgical instrumentsWELDON INSTRUMENTSGanjay Wali street Rai Pur Stop, Wazirabad Road, Sialkot, 51310, Pakistan 2024-06-25efficient
27Substitute OSSTEM IMPLANT Co., Ltd.66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea 2024-06-25change
28Dental implant depth gaugeThe most beautiful부산광역시북구효열로7 B1, 3F(금곡동) 2024-06-25efficient
29Drill depth stopThe most beautiful부산광역시북구효열로7 B1, 3F(금곡동) 2024-06-25efficient
30Transfer bodyThe most beautiful부산광역시북구효열로7 B1, 3F(금곡동) 2024-06-25efficient
31Implant ScannerThe most beautiful부산광역시북구효열로7 B1, 3F(금곡동) 2024-06-25efficient
32Dental implant guide fixing screwThe most beautiful부산광역시북구효열로7 B1, 3F(금곡동) 2024-06-25efficient
33Implant installation auxiliary equipmentThe most beautiful부산광역시북구효열로7 B1, 3F(금곡동) 2024-06-25efficient
34Dental forcepsThe most beautiful부산광역시북구효열로7 B1, 3F(금곡동) 2024-06-25efficient
35Suction tubeSONTEC INSTRUMENTS, INC.7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112 2024-06-25efficient
36Dental Knife 3R Industry and Commerce Eireli.290 Ptolomeu Street – Sao Paulo (SP)–Brazil–Zip Code: 04762-040 2024-06-25change
37Dental polishing strips3R Industry and Commerce Eireli.290 Ptolomeu Street – Sao Paulo (SP)–Brazil–Zip Code: 04762-040 2024-06-24change
38Tungsten carbide needle for dental finishing3R industry and commerce Eireli.290 Ptolomeu Street – Sao Paulo (SP) – Brazil – Zip Code: 04762-040 2024-06-24change
39Screw-in wrenchZefang Technology Co., Ltd.1F, No. 17, Lane 81, Lane 2, Section 1, Zhongxing Road, Dali District, Taichung City 2024-06-24change
40Urology and anorectal surgery instrumentsWELDON INSTRUMENTSGanjay Wali street Rai Pur Stop, Wazirabad Road, Sialkot, 51310, Pakistan 2024-06-24efficient
41Gynecological and obstetric surgical instrumentsWELDON INSTRUMENTSGanjay Wali street Rai Pur Stop, Wazirabad Road, Sialkot, 51310, Pakistan 2024-06-24efficient
42Orthopedic surgical instrumentsWELDON INSTRUMENTSGanjay Wali street Rai Pur Stop, Wazirabad Road, Sialkot, 51310, Pakistan 2024-06-24efficient
43Medical magnifying glassDermLite LLC21 Argonaut Unit A Aliso Viejo, CA 92656 USA 2024-06-24efficient
44Powdered plaster bandagePaul Hartmann AG Mala Bukovina 50, 552 04 Chvalkovice, Czech Republic 2024-06-24efficient
45Medical magnifying glass(주)인천광역시미추홀구석정로148 (숭의동) 2024-06-24change
46HandleSONTEC INSTRUMENTS, INC.7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112 2024-06-24efficient
47ProbeSONTEC INSTRUMENTS, INC.7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112 2024-06-24efficient
48Sample processing systemRoche Molecular Systems, Inc. Neuwiesenstrasse 4, 8222 Beringen, Switzerland 2024-06-21efficient
49Medical polymer splint3M Germany GmbHul. Kwidzyska 6 51-416 Wroclaw, Poland 2024-06-21invalid
50Ostomy skin care powderHollister Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA 2024-06-21change
51Ostomy bagHollister Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA; Foxford Road Rehins, Ballina, Co. Mayo Ireland; 1502 East LaHarpe Kirksville, MO 63501 USA 2024-06-21change
52Stoma base plateHollister Incorporated366 Draft Avenue Stuarts Draft, VA 24477 USA 2024-06-21change
53Ostomy bagHollister Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA 2024-06-21change
54Stoma base plateHollister Incorporated366 Draft Avenue Stuarts Draft, VA 24477 USA 2024-06-21change
55Ostomy bagHollister Incorporated366 Draft Ave STUARTS DRAFT,VA USA 24477 2024-06-21change
56Stoma base plateHollister Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA 2024-06-21change
57Ostomy bagHollister Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA 2024-06-21change
58Ostomy Care ProductsHollister Incorporated/ 2024-06-21change
59Ostomy Care Products Hollister Incorporated/ 2024-06-21change
60Ostomy Care ProductsHollister IncorporatedFjarrviksvagen 22, SE-653 50 Karlstad, Sweden 2024-06-21change
61Ostomy Care ProductsHollister Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA 2024-06-21change
62Ostomy bagHollister Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA 2024-06-20change
63Ostomy bagHollister Incorporated366 Draft Avenue Stuarts Draft, VA 24477 USA 2024-06-20change
64Ostomy bagHollister Incorporated 366 Draft Avenue Stuarts Draft, VA USA 24477 2024-06-20change
65Ostomy bagHollister Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA 2024-06-20change
66Endotracheal tube holder Hollister IncorporatedHollister Incorporated 366 Draft Avenue Stuarts Draft, VA USA 24477 2024-06-20change
67Stoma beltHollister IncorporatedSEI Medical SA de CV Roberto Fierro #6420 & Francisco Sarabia Parque Industrial Aeropuerto Juarez, Chihuahua, MEXICO 32685 2024-06-20change
68Anti-leakage creamHollister Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA 2024-06-20change
69 CD235a detection reagent (flow cytometry-FITC)Agilent Technologies Singapore (International) Pte. Ltd.Produktionsvej 42 DK-2600 Glostrup DENMARK 2024-06-20efficient
70CD41 Antibody Reagent (Flow Cytometry-FITC)Agilent Technologies Singapore (International) Pte Ltd.Produktionsvej 42 DK-2600 Glostrup DENMARK 2024-06-20efficient
71CD42b Antibody Reagent (Flow Cytometry-RPE)Agilent Technologies Singapore (International) Pte Ltd.Produktionsvej 42 DK-2600 Glostrup DENMARK 2024-06-20efficient
72CD235a detection reagent (flow cytometry-RPE)Agilent Technologies Singapore (International) Pte. Ltd. Produktionsvej 42 DK-2600 Glostrup DENMARK 2024-06-20efficient
73Vascular forcepsSONTEC INSTRUMENTS, INC.7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112 2024-06-20efficient
74RetractorSONTEC INSTRUMENTS, INC.7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112 2024-06-20efficient
75Adjustable fixation braceFengli International Co., Ltd.2nd and 3rd Floor, No. 13, Yongxing Road, Fuxing Village, Nantou City, Nantou County 2024-06-20efficient
76 Shoulder surgery toolsBiomet Orthopedics56 East Bell Drive PO Box 587 Warsaw Indiana 46581 USA 2024-06-20change
77Podoplanin Antibody ReagentsCell Marque Corporation 6600 Sierra College Blvd. Rocklin, CA 95677 USA 2024-06-20efficient
78PAX-8 Antibody ReagentsCell Marque Corporation 6600 Sierra College Blvd. Rocklin, CA 95677 USA 2024-06-20efficient
79Knee ImmobilizerFengli International Co., Ltd.2nd and 3rd Floor, No. 13, Yongxing Road, Fuxing Village, Nantou City, Nantou County 2024-06-20change
80Knee ImmobilizerFengli International Co., Ltd.2nd and 3rd Floor, No. 13, Yongxing Road, Fuxing Village, Nantou City, Nantou County 2024-06-20change
81Tissue scissorsSONTEC INSTRUMENTS, INC.7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112 2024-06-19efficient
82Tissue forcepsSONTEC INSTRUMENTS, INC.7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112 2024-06-19efficient
83FlusherSONTEC INSTRUMENTS, INC.7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112 2024-06-19efficient
84Needle HolderSONTEC INSTRUMENTS, INC.7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112 2024-06-19efficient
85CD123 Antibody ReagentsBioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121 2024-06-18efficient
86CD9 Antibody ReagentsBioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121 2024-06-18efficient
87Denture repair toolsZest Anchors, LLC2230 Enterprise Street, Escondido, California, 92029, USA 2024-06-18change
88Torque wrenchMIS Implants Technologies Ltd.Bar Lev Industrial Park,2015600 Israel 2024-06-18change
89ScrewdriverMIS Implants Technologies Ltd.Bar Lev Industrial Park,2015600 Israel 2024-06-18change
90Forming sheet3R Industry and Commerce Eireli.290 Ptolomeu Street – Sao Paulo (SP)–Brazil–Zip Code: 04762-040 2024-06-17change
91Grinding tool kit3R Industries and Comercio LtdaRUA PTOLOMEU,N°290-VILA SOCORRO-SÃO PAULO-SP CEP:04762-040 2024-06-17change
92Extraoral abrasive materials3R Industry and Commerce Eireli.290 Ptolomeu Street – Sao Paulo (SP)–Brazil–Zip Code: 04762-040 2024-06-17change
93Dental measuring tape 3R Industry and Commerce Eireli.290 Ptolomeu Street – Sao Paulo (SP)–Brazil–Zip Code: 04762-040 2024-06-17change
94Cryoembedding mediumSAKURA FINETEK USA, INC.1750 W 214th St TORRANCE, CA USA 90501 2024-06-14change
95Knee surgery instrumentsBlue Belt Technologies, Inc.76 South Meridian Ave Oklahoma City Oklahoma 73107-6512 USA 2024-06-13change
96StripperSONTEC INSTRUMENTS, INC.7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112 2024-06-13efficient
97Valve holderEdwards Lifesciences LLCOne Edwards Way Irvine, CA USA 92614 2024-06-13efficient
98Surgical headlightICLERCHER-Solutions GmbHIm Sägenloh 8, 78333 Stockach Germany 2024-06-12efficient
99Dental Implant Surgery KitCowellmedi Co., Ltd.48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea 2024-06-11change
100Dental finishing diamond needleEastern Power International Limited6F, No. 3, Bade Street, Shulin District, New Taipei City 2024-06-11efficient
101Sealing machineSakura Seiki Co., Ltd.75-5 Daimonomonoya, Chikuma City, Nagano Prefecture 2024-06-11efficient
102Forming sheet clamp placement forcepsSobytek Instruments Co.Roras Road, Muzaffar Pur, Sialkot 51310- Pakistan 2024-06-11efficient
103Head mounted inspection light(주)인천광역시중구서해대로180번길273층 2024-06-07efficient
104Planting aidsAnthogyr SAS2237 avenue André Lasquin, 74700 SALLANCHES FRANCE 2024-06-06change
105Dental surgery instrument kitCowellmedi Co., Ltd.48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea 2024-06-06change
106Implantation aid kitCowellmedi Co., Ltd.48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea 2024-06-06change
107Dental KitsCowellmedi Co., Ltd.48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea 2024-06-06change
108X-ray protection deviceKenex (Electro-Medical) LtdUnit 17, RO24 Greenway, Harlow Business Park, Harlow, Essex, CM19 5QB, UK 2024-06-06change
109Implant installation auxiliary equipmentIzenimplant Co., Ltd.1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do 2024-06-05change
110Sample extractAbbott Ireland Diagnostics Division940 Crossroads Blvd., Seguin, TX 78155 USA 2024-06-05efficient
111Sample extractAbbott Ireland Diagnostics Division940 Crossroads Blvd., Seguin, TX 78155 USA 2024-06-05efficient
112Fluorescence biological microscopeEUROIMMUN Medizinische Labordiagnostika AGAn der Trave 1, 23923 Selmsdorf, Germany 2024-06-05efficient
113BufferRoche Diagnostics GmbHSandhofer Strasse 116,68305 Mannheim,Germany 2024-06-05efficient
114Surgical auxiliary lightingMAQUET SASParc de Limere-Avenue de la Pomme de Pin, CS 10008 Ardon 45074 ORLEANS CEDEX 2 FRANCE 2024-06-05change
115Manual measuring instruments Izenimplant Co., Ltd.1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do 2024-06-05change
116Dental drill depth guide for implantsIzenimplant Co., Ltd.1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do 2024-06-04change
117Planting aidsIzenimplant Co., Ltd.1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do 2024-06-04change
118Polyurethane padded bandageLohmann & Rauscher International GmbH & Co. KGIrlicher Strasse 55, 56567 Neuwied, GERMANY 2024-06-04change
119Automatic electrophoresis instrumentSEBIAParc Technologique Léonard de Vinci, CP 8010 – Lisses 91008 EVRY CEDEX FRANCE 2024-06-04change
120Foot supportÖssur hfGrjotháls 1-5 Reykjavik 110 Iceland 2024-06-04change
121Orthopedic drill bitDENTEC CO., LTD.53-5 Kiyomizu-cho, Itabashi-ku, Tokyo 2024-06-04efficient
122Medical cooling patchTowa Pharmaceutical Co., Ltd.1229 Maruqi, Kishikawa-cho, Wakayama Prefectural Nokawa City 2024-06-03efficient
123Fundus wide-angle observation mirrorOCULUS Optikgeräte GmbHMünchholzhäuser Str.29, 35582 Wetzlar, Germany 2024-06-03change
124Cell Processing KitsOxford Immunotec Ltd.94C Innovation Drive Milton Park,Abingdon Oxfordshire,OX14 4RZ,UK 2024-06-03change
125Oral treatment appliancesNext Instruments410/E, Khadim Ali Road, Sialkot-51310-Pakistan 2024-06-03efficient
126Facial surgical instruments (package)Asia Pacific Medical Devices Technology Co., Ltd.No. 2, Gongsan Road, Xidi Village, Shengang Township, Changhua County 2024-06-03change