Total 106 public review reports published by CMDE in 2023

CMDE publish a total of 106 product technical reviews reports in 2023. The following is the list of the reports:

• Mammography X-ray image-assisted detection software (CQZ2200165) (2023-01-03)

• Twenty hereditary deafness gene mutation detection kit (time-of-flight mass spectrometry) (CSZ1900358) (2023-01-04)

• Patient monitor (CQZ2000927) (2023-01-04)

• Dental laser selective melting of pure titanium powder (CQZ2000516) (2023-01-11)

• HLA-B*1301 gene detection kit (PCR-fluorescent probe method) (CSZ2100268) (2023-02-06)

• Hybrid closed-loop insulin infusion system (JQZ2200010) (2023-02-23)

• Hemodialysis urea clearance calculation software (CQZ2200128) (2023-02-23)

• Nitric oxide therapy device (CQZ2200018) (2023-02-23)

• Human CYP2C19 Genotyping Detection Kit (Time of Flight Mass Spectrometry) (CSZ2000242) (2023-02-27)

• Portable first aid equipment (CQZ2101491) (2023-03-02)

• Cervical cytology digital pathology image computer-aided analysis software (CQZ2101339) (2023-03-03)

• Cerebrovascular interventional surgery auxiliary system (CQZ2200254) (2023-03-06)

• Aspergillus, Cryptococcus neoformans and Pneumocystis jiroveci nucleic acid detection kit (PCR fluorescent probe method) (CSZ2100192) (2023-03-09)

• Metal additive manufacturing matching long-segment bone defect restoration (CQZ2200418) (2023-03-21)

• Magnetic resonance monitoring semiconductor laser treatment equipment (CQZ2200298) (2023-03-30)

• Coronary CT blood flow reserve fractional calculation software (CQZ2200284) (2023-03-31)

• Collagen cartilage repair scaffold (JQZ2200176) (2023-03-31)

• Disposable laser fiber kit (CQZ2200361) (2023-04-08)

• Intraocular lens (JQZ2100554) (2023-04-13)

• Coronary artery function measurement system (CQZ2200521) (2023-04-14)

• Metal additive manufacturing thoracolumbar fusion matching prosthesis system (CQZ2200405) (2023-04-19)

• Intestinal polyps electronic lower gastrointestinal endoscopy image-assisted detection software (CQZ2200536) (2023-04-20)

• Prostate puncture positioning equipment (JQZ2200262) (2023-05-09)

• Self-expandable particle-carrying biliary stent (CQZ2200320) (2023-05-09)

• Intravascular imaging equipment (JQZ2200189) (2023-05-15)

• Radiation treatment planning software (CQZ2101192) (2023-05-16)

• Colon polyps electronic endoscopic image-assisted detection software (CQZ2200455) (2023-05-18)

• Disposable coronary interventional surgery control system accessories (JQZ2200043) (2023-05-22)

• Coronary interventional surgery control system (JQZ2200044) (2023-05-22)

• Intraocular lens (CQZ2300086) (2023-05-31)

• Carbon ion therapy system (CQZ2300782) (2023-06-02)

• Implantable left ventricular assist system (CQZ2300116) (2023-06-02)

• Multimodal tumor treatment system (CQZ2201569) (2023-06-07)

• Implantable sacral nerve stimulation electrode (CQZ2101044) (2023-06-09)

• Implantable sacral nerve stimulation extension lead (CQZ2101042) (2023-06-09)

• Implantable sacral nerve stimulator (CQZ2101040) (2023-06-09)

• Zirconium-niobium alloy femoral head (CQZ2200344) (2023-06-12)

• Puncture surgery navigation and positioning system (CQZ2201581) (2023-06-14)

• High-risk human papillomavirus nucleic acid detection kit (fluorescence PCR method) (CSX2100396) (2023-06-15)

• Shock wave therapy device (CQZ2200771) (2023-06-16)

• Laparoscopic single-port surgery system (CQZ2201673) (2023-06-16)

• Head and neck X-ray stereotactic radiosurgery system (JQZ2100725) (2023-06-19)

• Embryo culture medium (CQZ2200368) (2023-06-19)

• BMPR1A/PLAC8 gene methylation detection kit (digital PCR method) (CSZ2200341) (2023-06-20)

• HLA class II single antigen specific antibody detection kit (flow fluorescence immunoassay) (JSZ2000062) (2023-06-26)

• HLA class I single antigen specific antibody detection kit (flow fluorescence immunoassay) (JSZ2000045) (2023-06-27)

• Knee prosthesis (JQZ2100213) (2023-07-04)

• Peripherally scored drug balloon dilation catheter (CQZ2200553) (2023-07-07)

• Human SDC2, NPY, FGF5, PDX1 gene methylation detection kit (fluorescence PCR method) (CSZ2100041) (2023-07-10)

• Klebsiella pneumoniae and carbapenem resistance gene KPC detection kit (fluorescence PCR method) (CSZ2000070) (2023-07-10)

• Ischemic stroke CT image auxiliary assessment software (CQZ2201543) (2023-07-11)

• Knee replacement surgery navigation and positioning system (CQZ2201250) (2023-07-11)

• Intraocular lens (JQZ2200021) (2023-07-18)

• Venous stent system (CQZ2201305) (2023-07-24)

• Medical electron linear accelerator (CQZ2201580) (2023-07-26)

• Disposable intravascular imaging catheter (JQZ2200144) (2023-07-26)

• Rigid scleral contact lenses (CQZ2201345) (2023-07-28)

• Hip replacement surgery navigation and positioning system (CQZ2201499) (2023-08-07)

• Human BRAF/TERT/CCDC6-RET gene mutation detection kit (fluorescence PCR method) (CSZ2100333) (2023-08-14)

• Lung perfusion system (JQZ2100031) (2023-08-14)

• Magnetic resonance imaging system (CQZ2200184) (2023-08-14)

• Intracranial thrombectomy stent (JQZ2200082) (2023-08-16)

• Balloon cryoablation catheter (CQZ2201490) (2023-08-21)

• Blue light filtering intraocular lens (CQZ2101454) (2023-08-21)

• Cryoablation equipment (CQZ2201518) (2023-08-21)

• Recombinant type III humanized collagen solution for injection (CQZ2201584) (2023-08-22)

• Bone repair materials (JQZ2100518) (2023-08-24)

• Mitral valve clamp system (CQZ2200977) (2023-08-31)

• Human PDGFRA gene D842V mutation detection kit (PCR-fluorescent probe method) (CSZ2100134) (2023-09-12)

• Magnetic resonance image auxiliary evaluation software (CQZ2201033) (2023-09-14)

• Disposable hemoperfusion device (CQZ2201401) (2023-09-26)

• Non-small cell lung cancer tissue TMB detection kit (reversible end termination sequencing method) (CSZ2200142) (2023-09-27)

• X-ray computed tomography equipment (JQZ2300008) (2023-10-08)

• Hepatitis E virus antigen urine detection kit (fluorescence immunochromatography) (CSZ2100106) (2023-10-09)

• Hepatitis E virus antigen urine detection kit (colloidal gold method) (CSZ2100063) (2023-10-09)

• Knee prosthesis component-femoral component (JQZ2200023) (2023-10-12)

• Joint replacement surgery simulation software (CQZ2300166) (2023-10-16)

• Plasma therapy device (CQZ2201332) (2023-10-18)

• Human microsatellite instability (MSI) detection kit (fluorescence PCR-capillary electrophoresis) (CSZ2100212) (2023-10-24)

• Blood glucose meter (JQZ2100660) (2023-10-26)

• Proton therapy system (JQZ2300315) (2023-10-30)

• Electronic lower digestive tract image-assisted detection software for intestinal polyps (CQZ2200605) (2023-11-02)

• Single photon emission and X-ray computed tomography system (CQZ2300344) (2023-11-02)

• Thyroid nodule ultrasound imaging-assisted diagnosis software (CQZ2200673) (2023-11-03)

• Autologous fat and fat matrix component recovery equipment (CQZ2200351) (2023-11-03)

• Additive manufacturing of polyetheretherketone skull defect repair prosthesis (CQZ2201553) (2023-11-03)

• PD-L1 Antibody Reagent (Immunohistochemistry) (CSZ2200100) (2023-11-06)

• Intracranial aneurysm CT angiography image-assisted triage software (CQZ2300190) (2023-11-07)

• Additive manufacturing matching artificial knee prosthesis (CQZ2300395) (2023-11-15)

• Laparoscopic single-port surgery system (CQZ2300239) (2023-11-17)

• Streptococcus pneumoniae/Mycoplasma pneumoniae/Haemophilus influenzae nucleic acid joint detection kit (PCR-fluorescent probe method) (CSZ2100124) (2023-11-20)

• MR image-assisted triage software for focal liver lesions (CQZ2201476) (2023-11-22)

• Disposable intracardiac ultrasound diagnostic catheter (CQZ2300664) (2023-11-24)

• Gelatin-polycaprolactone layered gum repair film (CQZ2201538) (2023-11-28)

• Transcatheter Mitral Valve Clamp System (CQZ2300388) (2023-11-28)

• Cryoablation equipment (CQZ2200850) (2023-11-28)

• Balloon cryoablation catheter (CQZ2200781) (2023-11-28)

• Pelvic fracture reduction surgery navigation and positioning system (CQZ2201432) (2023-12-01)

• Biodegradable magnesium metal closure clip (CQZ2201178) (2023-12-06)

• Pulmonary artery radiofrequency ablation device (CQZ2200777) (2023-12-06)

• Disposable circular pulmonary artery radiofrequency ablation catheter (CQZ2200784) (2023-12-06)

• Human breast cancer molecular typing detection kit (PCR-fluorescent probe method) (JSZ2000087) (2023-12-14)

• Disposable cardiac pulsed electric field ablation catheter (CQZ2300346) (2023-12-21)

• Cardiac pulsed electric field ablation device (CQZ2300348) (2023-12-21)

• Proton therapy system (JQZ2300157) (2023-12-21)

• Human immunodeficiency virus type 1 (HIV-1) nucleic acid detection kit (PCR-fluorescent probe method) (CSZ2200292) (2023-12-22)