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In June 2021, the State Drug Administration approved and registered 163 medical device products
.
Among them, there are 110 domestic third-class medical device products, 28 imported third-class medical device products, 23 imported second-class medical device products, and 2 medical device products from Hong Kong, Macao and Taiwan (see attachment for specific products)
.
Hereby announce
.
Attachment: List of Medical Devices Approved for Registration in June 2021
National Food and Drug Administration July 12, 2021
.
Among them, there are 110 domestic third-class medical device products, 28 imported third-class medical device products, 23 imported second-class medical device products, and 2 medical device products from Hong Kong, Macao and Taiwan (see attachment for specific products)
.
Hereby announce
.
Attachment: List of Medical Devices Approved for Registration in June 2021
| Serial number | product name | Registrant name | Registration number |
|---|---|---|---|
| Domestic Class III medical devices |
|||
| 1 | Fully automatic medical PCR analysis system | Xiamen Zhishan Biotechnology Co. , Ltd. | National Machinery Note 20213220383 |
| 2 | Three-dimensional electronic abdominal endoscopy | MicroPort (Shanghai) Medical Robot Co. , Ltd. | National Machinery Note 202113060384 |
| 3 | Single-use medicated cervical dilation rod | Tianjin Hejie Medical Equipment Co. , Ltd. | National Machinery Note Standard 20113180385 |
| 4 | Lacrimal drainage tube for single use | Shandong Benos Medical Equipment Co. , Ltd. | National Machinery Injection Standard 20213160386 |
| 5 | Facial Cone Lifting Line | Zhejiang Weidu Medical Equipment Co. , Ltd. | National Machinery Note 20113130387 |
| 6 | Vertebroplasty System | Chuanghui Medical Equipment Jiangsu Co. , Ltd. | National Machinery Note 202113040388 |
| 7 | Disposable precision filter infusion set with needle | Jiangxi Hongda Medical Equipment Group Co. , Ltd. | National Machinery Note 20113140389 |
| 8 | Single-use high-pressure radiography syringe and accessories | Dongguan Yixing Medical Technology Co. , Ltd. | National Machinery Note 202113060390 |
| 9 | Single use microcatheter kit | Dalian Kuliat Medical Products Co. , Ltd. | National Machinery Note 202113030391 |
| 10 | One-time use pressure extension tube | Hengyi (Beijing) Medical Technology Co. , Ltd. | National Machinery Note 20 113140392 |
| 11 | Single use sterile retractable self-destructing syringe with needle | Shandong Zhushi Pharmaceutical Group Co. , Ltd. | National Machinery Note 20 113140393 |
| 12 | Neuro Intervention Microcatheter | Shenzhen Miele MicroPort Medical Technology Co. , Ltd. | National Machinery Note 202113030394 |
| 13 | Hydrocolloid dressing | Zhejiang Longtai Medical Technology Co. , Ltd. | National Machinery Note 20 113140395 |
| 14 | Single use arterial indwelling needle | Shenzhen Yixinda Medical New Technology Co. , Ltd. | National Machinery Note 20 113140396 |
| 15 | Metal locking intramedullary nail system | Beijing Montain Medical Equipment Co. , Ltd. | National Machinery Note 20 113130397 |
| 16 | Partially absorbable hernia repair patch | Tianjin Baihe Zhiyuan Medical Technology Co. , Ltd. | National Machinery Note 20 113130398 |
| 17 | Disposable precision filter infusion set | Chengdu Xinjinshifeng Medical Equipment Co. , Ltd. | National Machinery Note 20 113140399 |
| 18 | Absorbable skull lock | Chengdu Meida Medical Technology Co. , Ltd. | National Machinery Injection Standard 20113130400 |
| 19 | Vertebral body expansion balloon catheter | Tianjin Zhengtian Medical Devices Co. , Ltd. | National Machinery Note 202113040401 |
| 20 | Contrast guide wire | Anjite (Tianjin) Technology Co. , Ltd. | National Machinery Note 202113030402 |
| twenty one | Microcatheter | Hemu (China) Biological Engineering Co. , Ltd. | National Machinery Note 202113030403 |
| twenty two | Balloon guiding catheter | Zhejiang Guichuang Medical Equipment Co. , Ltd. | National Machinery Note 202113030404 |
| twenty three | One-time use anti-needle venous blood sampling needle | Henan Tuoren Medical Technology Co. , Ltd. | National Machinery Note 20213220405 |
| twenty four | Meniscus Suture System | Beijing Deyi Damei Medical Technology Co. , Ltd. | National Machinery Injection Standard 20113130406 |
| 25 | Human Papillomavirus (HPV) Genotyping Test Kit (Fluorescent PCR Melting Curve Method) | Shanghai Fosun Long March Medical Science Co. , Ltd. | National Machinery Note 20113400409 |
| 26 | Enterovirus universal, EV-71 and CA-16 nucleic acid detection kit (PCR-fluorescence method) | Suzhou Huayimei Biotechnology Co. , Ltd. | National Machinery Note 20213400410 |
| 27 | CD3-FITC/CD8-PE/CD45-PerCP/CD4-APC fluorescent monoclonal antibody kit (flow cytometry method) | Tianjin Kuangbo Tongsheng Biotechnology Co. , Ltd. | National Machinery Note 20213400411 |
| 28 | CD3-FITC/CD16+CD56-PE/CD45-PerCP/CD19-APC fluorescent monoclonal antibody kit (flow cytometry method) | Tianjin Kuangbo Tongsheng Biotechnology Co. , Ltd. | National Machinery Note 20213400412 |
| 29 | CD3-FITC/CD16+56-PE/CD45-PerCP-Cy5. 5/CD4-PC7/CD19-APC/CD8-APC-Cy7 fluorescent monoclonal antibody kit (flow cytometry method) | Tianjin Kuangbo Tongsheng Biotechnology Co. , Ltd. | National Machinery Note 20113400413 |
| 30 | Cancer antigen 15-3 (CA15-3) determination kit (chemiluminescence method) | Guangzhou Kefang Biotechnology Co. , Ltd. | National Machinery Note 20113400414 |
| 31 | Cytokeratin 19 Fragment (CYFRA21-1) Assay Kit (Chemiluminescence Method) | Guangzhou Kefang Biotechnology Co. , Ltd. | National Machinery Note 20113400415 |
| 32 | Kit for determination of alpha-fetoprotein (AFP) (chemiluminescence method) | Guangzhou Kefang Biotechnology Co. , Ltd. | National Machinery Note 20113400416 |
| 33 | Carcinoembryonic antigen (CEA) determination kit (chemiluminescence method) | Guangzhou Kefang Biotechnology Co. , Ltd. | National Machinery Note 20113400417 |
| 34 | Mycoplasma pneumoniae nucleic acid detection kit (PCR-fluorescent probe method) | Sun Yat-sen University Daan Gene Co. , Ltd. | National Machinery Note 20113400418 |
| 35 | ABO/Rh blood group antigen test card (microcolumn gel method) | Shenzhen Akcome Reagent Co. , Ltd. | National Machinery Note 20113400419 |
| 36 | Kit for determination of total prostate specific antigen (chemiluminescence immunoassay) | Shenzhen New Industries Biomedical Engineering Co. , Ltd. | National Machinery Note 20113400420 |
| 37 | Anesthesia Machine | Shenzhen Mindray Biomedical Electronics Co. , Ltd. | National Machinery Note 202113080421 |
| 38 | Diabetic retinopathy fundus image-aided diagnosis software | Beijing Zhiyuan Huitu Technology Co. , Ltd. | National Machinery Note 20213210422 |
| 39 | Portable electric infusion pump | Jiangsu Aipen Medical Technology Co. , Ltd. | National Machinery Note 20 113140423 |
| 40 | Blood glucose meter | Changzhou Xiruojia Medical Technology Co. , Ltd. | National Machinery Note 202113070424 |
| 41 | Semiconductor laser hair removal machine | Jilin Keying Laser Co. , Ltd. | National Machinery Note 202113090425 |
| 42 | Porous metal bone implants | Beijing Aikang Yicheng Medical Equipment Co. , Ltd. | National Machinery Injection Standard 20113130426 |
| 43 | Disposable intravenous indwelling needle | Shanghai Jinze Xiaben Medical Equipment Co. , Ltd. | National Machinery Note 20 113140427 |
| 44 | Guide wire | Shenzhen Miele MicroPort Medical Technology Co. , Ltd. | National Machinery Note 202113030428 |
| 45 | Cemented total knee prosthesis | Shandong Xinhua United Orthopedic Equipment Co. , Ltd. | National Machinery Note 20113130429 |
| 46 | Culture oil | Ayers (Zhejiang) Medical Technology Co. , Ltd. | National Machinery Note 20 113180430 |
| 47 | One-time use needleless connector | Changzhou Medical Equipment General Factory Co. , Ltd. | National Machinery Note 20 113140431 |
| 48 | Metal spicule | Shijiazhuang Dabang Medical Equipment Factory | National Machinery Note 20 113130432 |
| 49 | Soft hydrophilic contact lens | Haichang Contact Lens Co. , Ltd. | National Machinery Injection Standard 202113160433 |
| 50 | Carotid artery balloon dilatation catheter | Weiming Medical Equipment (Shanghai) Co. , Ltd. | National Machinery Note 202113030434 |
| 51 | Anterior Cervical Fixation System | Ningbo Huakerun Biological Technology Co. , Ltd. | National Machinery Note 20113130435 |
| 52 | Multi-loop measuring perfusion catheter | Shanghai Kangdelai Medical Equipment Co. , Ltd. | National Machinery Note 202113030436 |
| 53 | Intermediate catheter for single use | Beijing Taijie Weiye Technology Co. , Ltd. | National Machinery Note 202113030437 |
| 54 | Dedicated needle for disposable implantable drug delivery device | Suzhou Bidi Medical Equipment Co. , Ltd. | National Machinery Note 20113140438 |
| 55 | Catcher | Zhejiang Guichuang Medical Equipment Co. , Ltd. | National Machinery Note Standard 20213030439 |
| 56 | Intracranial electrolytic detachable coil | Shanghai Jiaqi Biological Technology Suzhou Co. , Ltd. | National Machinery Injection Standard 20113130440 |
| 57 | Hemodialysis powder | Jilin Fusheng Medical Equipment Co. , Ltd. | National Machinery Note 20113100441 |
| 58 | Flexible wire | Jomaikang (Xiamen) Medical Devices Co. , Ltd. | National Machinery Note 20 113130442 |
| 59 | Non-absorbable cord anchor | Fangrun Medical Device Technology (Shanghai) Co. , Ltd. | National Machinery Note 20113130443 |
| 60 | Infusion extension tube | Jiangxi Huali Medical Equipment Co. , Ltd. | National Machinery Note 20113140444 |
| 61 | Dedicated needle for implantable drug delivery device | Jiangxi Huali Medical Equipment Co. , Ltd. | National Machinery Note 20113140445 |
| 62 | Disposable ligation clip | Changzhou Medical Equipment General Factory Co. , Ltd. | National Machinery Note 202113020446 |
| 63 | Precision light-proof extension tube for one-time use | Jiangxi Hongda Medical Equipment Group Co. , Ltd. | National Machinery Note 20113140447 |
| 64 | Biological Femoral Stem Components | Johnson & Johnson (Suzhou) Medical Equipment Co. , Ltd. | National Machinery Note 20113130448 |
| 65 | Hemodialysis concentrate | Huayu (Wuxi) Pharmaceutical Co. , Ltd. | National Machinery Note 20 113100449 |
| 66 | Vertebral body expansion balloon catheter | Changzhou Huasen Medical Equipment Co. , Ltd. | National Machinery Note 202113040450 |
| 67 | PTA balloon dilatation catheter | Teresa Medical Technology (Wuhan) Co. , Ltd. | National Machinery Note 202113030451 |
| 68 | Metal cable system | Boyining (Xiamen) Medical Devices Co. , Ltd. | National Machinery Note 20 113130452 |
| 69 | Selective melting of cobalt-based alloy powder by dental laser | Guangzhou Nalian Material Technology Co. , Ltd. | National Machinery Note 20 113170453 |
| 70 | Intracranial balloon dilatation catheter | Beijing Jiushi Shenkang Medical Technology Co. , Ltd. | National Machinery Note 202113030454 |
| 71 | Non-compliant peripheral balloon dilatation catheter | Beijing Yongyi Runcheng Technology Co. , Ltd. | National Machinery Note 202113030455 |
| 72 | Interbody fusion cage | Beijing Fule Technology Development Co. , Ltd. | National Machinery Note 20 113130456 |
| 73 | One-piece hydrophobic aspheric intraocular lens | Aibo Nord (Beijing) Medical Technology Co. , Ltd. | National Machinery Note 20213160457 |
| 74 | Non-compliant balloon dilatation catheter | Shanghai Kangdelai Medical Equipment Co. , Ltd. | National Machinery Note 202113030458 |
| 75 | Rib bone plate | Chuanghui Medical Equipment Jiangsu Co. , Ltd. | National Machinery Note 20 113130459 |
| 76 | Cross-linked sodium hyaluronate gel containing L-lactic acid-glycol copolymer microspheres | Amic Technology Development Co. , Ltd. | National Machinery Injection Standard 20113130460 |
| 77 | Hip prosthesis | Dabo Medical Technology Co. , Ltd. | National Machinery Injection Standard 20113130461 |
| 78 | Disposable light-proof infusion set with needle | Chengdu Xinjinshifeng Medical Equipment Co. , Ltd. | National Machinery Note 20113140462 |
| 79 | Hemodialysis machine | Jiangxi Sanxin Medical Technology Co. , Ltd. | National Machinery Note Standard 20113100463 |
| 80 | Transcatheter Aortic Valve System | Peijia Medical Technology (Suzhou) Co. , Ltd. | National Machinery Note 20113130464 |
| 81 | UGT1A1 Gene Polymorphism Detection Kit (Fluorescence PCR Method) | Shanghai Keyi Biotechnology Co. , Ltd. | National Machinery Note 20113400465 |
| 82 | Cross-matching blood quality control products | Tianjin Tegent Biotechnology Co. , Ltd. | National Machinery Injection Standard 20113400466 |
| 83 | Mycoplasma pneumoniae IgM/IgG antibody detection kit (colloidal gold method) | Beijing Zhongjian Antai Diagnostic Technology Co. , Ltd. | National Machinery Note Standard 20113400467 |
| 84 | Cancer antigen 125 (CA125) determination kit (chemiluminescence method) | Guangzhou Kefang Biotechnology Co. , Ltd. | National Machinery Injection Standard 20113400468 |
| 85 | Kit for determination of total prostate specific antigen (tPSA) (chemiluminescence method) | Guangzhou Kefang Biotechnology Co. , Ltd. | National Machinery Note 20113400469 |
| 86 | Human immunodeficiency virus (HIV-1) nucleic acid detection kit (fluorescence PCR method) | Suzhou Xinbo Biotechnology Co. , Ltd. | National Machinery Injection Standard 20113400470 |
| 87 | CT image-assisted detection software for lung nodules | Shanghai Lianying Intelligent Medical Technology Co. , Ltd. | National Machinery Note 20213210471 |
| 88 | Oral and maxillofacial cone beam computerized tomography equipment | Shenzhen Shentu Medical Imaging Equipment Co. , Ltd. | National Machinery Note 202113060472 |
| 89 | Automatic constant temperature nucleic acid amplification analyzer | Shanghai Suchuang Diagnostic Products Co. , Ltd. | National Machinery Note 20213220473 |
| 90 | Microwave hyperthermia machine | Shanghai Sorrento Medical Technology Co. , Ltd. | National Machinery Note 202113090474 |
| 91 | Oral and maxillofacial cone beam computerized tomography equipment | Shenzhen Anjian Technology Co. , Ltd. | National Machinery Note 202113060475 |
| 92 | Nerve monitoring endotracheal intubation | Shanghai Yingshou Medical Equipment Co. , Ltd. | National Machinery Note 202113070476 |
| 93 | Magnetic resonance imaging system | Philips Medical (Suzhou) Co. , Ltd. | National Machinery Note 202113060477 |
| 94 | Oral and maxillofacial cone beam computerized tomography equipment | Youfang (Hefei) Medical Technology Co. , Ltd. | National Machinery Note 202113060478 |
| 95 | Superconducting magnetic resonance imaging system | Beijing Wandong Medical Technology Co. , Ltd. | National Machinery Note 202113060479 |
| 96 | Baby monitoring warming station | Shenzhen Keman Medical Equipment Co. , Ltd. | National Machinery Note 202113080480 |
| 97 | External defibrillator monitor | Shenzhen Keman Medical Equipment Co. , Ltd. | National Machinery Note 202113080481 |
| 98 | Disposable needleless infusion connector sterilization cap | Baihe Medical Technology (Wuhan) Co. , Ltd. | National Machinery Note 202113030482 |
| 99 | Oral absorbable biofilm | Shenzhen Lando Biomaterials Co. , Ltd. | National Machinery Note 20213170483 |
| 100 | Rib bone plate | Jiangsu Qianrui Medical Equipment Co. , Ltd. | National Machinery Note 20 113130484 |
| 101 | Distal access catheter | Syncano Medical Technology (Shanghai) Co. , Ltd. | National Machinery Note 202113030485 |
| 102 | Distal access guide catheter | Shanghai Jiaqi Biological Technology Suzhou Co. , Ltd. | National Machinery Note 202113030486 |
| 103 | Pull-back fixed-dose self-destructing syringe with needle | Hunan Pingan Medical Equipment Technology Co. , Ltd. | National Machinery Note 20 113140487 |
| 104 | Recombinant type Ⅲ humanized collagen freeze-dried fiber | Shanxi Jinbo Biological Medicine Co. , Ltd. | National Machinery Note 20 113130488 |
| 105 | Non-absorbable ligament fixation screw | Fangrun Medical Device Technology (Shanghai) Co. , Ltd. | National Machinery Note 20 113130489 |
| 106 | Disposable precision filter infusion set with needle | Jiangxi Hongda Medical Equipment Group Co. , Ltd. | National Machinery Note 20 113140490 |
| 107 | Disposable infusion set with needle | Jiangxi Hongda Medical Equipment Group Co. , Ltd. | National Machinery Note 20 113140491 |
| 108 | Single use epidural anesthesia catheter | Zhongshan Pulis Minimally Invasive Interventional Medical Devices Co. , Ltd. | National Machinery Note 202113080492 |
| 109 | Disposable intravenous indwelling needle | Weihai Jierui Medical Products Co. , Ltd. | National Machinery Note 20213140493 |
| 110 | Disposable infusion set with needle | Jiangxi Hongda Medical Equipment Group Co. , Ltd. | National Machinery Note 20 113140494 |
| Imported third-class medical devices |
|||
| 111 | Soft hydrophilic contact lens | Visco Technology Sdn. Bhd. | 20213160195 |
| 112 | | Visco Technology Sdn. Bhd. | 20213160196 |
| 113 | | Hill-Rom Services Pte. Ltd. | 20213080197 |
| 114 | | Stryker Neurovascular | 20213030198 |
| 115 | | Medtronic Sofamor Danek USA, Inc. | 20213130199 |
| 116 | | ConTAC KOREA CORPORATION | 20213140204 |
| 117 | | （） | 20213030205 |
| 118 | PTCA | Biosensors Europe SA | 20213030206 |
| 119 | | Biosensors Europe SA | 20213130207 |
| 120 | | Balt Extrusion SAS | 20213030208 |
| 121 | | Menicon Co. ,Ltd. | 20213160209 |
| 122 | | Ethicon LLC | 20213020210 |
| 123 | | ArthroCare Corporation | 20213130211 |
| 124 | | Medos International SARL | 20213130212 |
| 125 | | Bausch & Lomb Incorporated | 20213160213 |
| 126 | — | Howmedica Osteonics Corp. | 20213130214 |
| 127 | | Nikkiso Belgium bvba | 20213100215 |
| 128 | | Boston Scientific Corporation | 20213130216 |
| 129 | PD-L1 （SP142）（） | Roche Diagnostics GmbH | 20213400224 |
| 130 | | HOYA | 20213060225 |
| 131 | | HOYA | 20213060226 |
| 132 | | HOYA | 20213060227 |
| 133 | | Impulse Dynamics （USA）, Inc. | 20213120228 |
| 134 | | Aktina Medical Corporation | 20213050229 |
| 135 | | DiaMed GmbH | 20213220230 |
| 136 | | BIOTRonIK SE & Co. KG | 20213120231 |
| 137 | | QUANTEL MEDICAL | 20213160232 |
| 138 | | Sequent Medical Inc. | 20213130233 |
| |
|||
| 139 | （） | Ascensia Diabetes Care Holdings AG | 20212400183 |
| 140 | C（） | Roche Diagnostics GmbH | 20212400184 |
| 141 | -6 （） | Siemens Healthcare Diagnostics Inc. | 20212400185 |
| 142 | （） | ARKRAY Factory, Inc. | 20212400186 |
| 143 | | ARKRAY Factory, Inc. | 20212400187 |
| 144 | D- | SYSMEX CORPORATION | 20212400188 |
| 145 | | Becton, Dickinson and Company，BD Biosciences | 20212220189 |
| 146 | X | GENERAL MEDICAL MERATE SPA | 20212060190 |
| 147 | X | GENERAL MEDICAL MERATE SPA | 20212060191 |
| 148 | | Beckman Coulter, Inc. | 20212220192 |
| 149 | | FUJIFILM Medical Systems U. S. A. ,Inc. | 20212210193 |
| 150 | | Planmeca Oy | 20212170194 |
| 151 | | GIMMI GmbH | 20212020200 |
| 152 | | Gebr. Brasseler GmbH & Co. KG | 20212170201 |
| 153 | | Bard Peripheral Vascular, Inc. | 20212140202 |
| 154 | | EMD Endoszkóp Mszer Gyártó és Kereskedelmi Kft. | National Machinery Injection into 20212030203 |
| 155 | Dental implant machine | W&H Dentalwerk Bürmoos GmbH | National Machinery Injection 20122170217 |
| 156 | Oral Curved Body Layer X-ray Machine | OWANDY RADIOLOGY SAS | National Machinery Injection into 20212060218 |
| 157 | Medical temperature controller | Medivance Inc. | National Machinery Injection into 20212090219 |
| 158 | Medical image processing software | TOMTEC Imaging Systems GmbH | National Machinery Injection into 202122102220 |
| 159 | Electric hospital bed | LINET spol. s ro | National Machinery Injection 20212150221 |
| 160 | Medical diagnostic X-ray tube assembly | キャャン electron tube Debeis Co. , Ltd. | National Machinery Injection into 20212060222 |
| 161 | Mobile ECG atrial fibrillation reminder software | Apple Inc. | National Machinery Injection into 20212210223 |
| Hong Kong, Macao and Taiwan medical equipment |
|||
| 162 | Tibia intramedullary nail system | Apex Biotechnology Co. , Ltd. | National Machinery Note 20213130008 |
| 163 | Electric operating table | Omega Co. , Ltd. | National Machinery Note 20212150009 |
National Food and Drug Administration July 12, 2021
