DeviceEstablishmentPulse: Foreign establishment, page 4 of 4
Records 351 to 500 of the 500 newest listed for this hub. Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
| Record | Role | New listings | Devices |
|---|---|---|---|
| Optikal (Southgate) Ltd | Foreign exporter | 3 | Lenses, Soft Contact, Extended Wear; Lenses, Soft Contact, Daily Wear; Lens, Contact, (Disposable) |
| Dalian Sportech Apparel Co., Ltd | Contract manufacturer | 1 | Accelerator, Linear, Medical |
| Soher Med Limited | Foreign exporter | 257 | Resin, Denture, Relining, Repairing, Rebasing; Crown And Bridge, Temporary, Resin; Material, Tooth Shade, Resin; Cement, Dental; Toothbrush, Manual; Activator, Ultraviolet, For Polymerization; Agent, Tooth Bonding, Resin; Varnish, Cavity; Instrument, Diamond, Dental; Coating, Filling Material, Resin |
| Loudwater Trade Finance Ltd | Foreign exporter | 3 | Tube, Tracheostomy (W/Wo Connector); Tube Tracheostomy And Tube Cuff |
| Medwell Technology Limited | Contract manufacturer | 1 | Syringe, Piston |
| Yizur Ltd | Foreign exporter | 100 | Toothbrush, Manual; Scissors, Orthopedic, Surgical; Mask, Surgical; Holder, Film, X-Ray; Paper, Articulation; System, X-Ray, Extraoral Source, Digital; Disk, Abrasive; Patient Personal Hygiene Kit; Knife, Surgical; Alloy, Metal, Base |
| Guangdong Youmeng Electrical Technology Co., Ltd. | Contract manufacturer | 2 | Pump, Breast, Powered |
| Suzhou Baili Medical Supplies Co.,Ltd | Contract manufacturer | 1 | Gown, Surgical |
| Shenzhen Baichang Technology Co., Ltd | Contract manufacturer | 1 | Pad, Heating, Powered |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Contract manufacturer | 1 | Ventilator, Non-Continuous (Respirator) |
| Nas Med LLC Fz | Foreign exporter | 7 | Electrosurgical, Cutting & Coagulation & Accessories; Mesh, Surgical, Polymeric; Staple, Implantable; System, Surgical, Computer Controlled Instrument |
| Amsino Medical (Kunshan) Co., Ltd. | Contract manufacturer | 1 | Urinary Irrigation Kit |
| Ronexmed S.A.S. | Contract manufacturer | 3 | Cannula, Nasal, Oxygen; Needle, Aspiration And Injection, Disposable; Cover, Mattress (Medical Purposes) |
| Jumao Medical Equipment (Cambodia) Co., Ltd. | Contract manufacturer | 2 | Generator, Oxygen, Portable; Wheelchair, Mechanical |
| Pt Medtech Th Co., Ltd | Contract manufacturer | 1 | Hysteroscope (And Accessories) |
| W&H Impex Inc. | Foreign exporter | 5 | Handpiece, Direct Drive, Ac-Powered; Controller, Foot, Handpiece And Cord; Scaler, Ultrasonic; Drill, Bone, Powered; Bur, Surgical, General & Plastic Surgery |
| Topcon Yamagata Co., LTD | Contract manufacturer | 2 | Biomicroscope, Slit-Lamp, Ac-Powered; Camera, Ophthalmic, Slit-Scanning |
| Medres Medical Engineering Ltd. | Contract manufacturer | 1 | Hysteroscope (And Accessories) |
| Jinhua Jingdi Medical Supplies Co.,Ltd | Contract manufacturer | 6 | Strip, Adhesive, Closure, Skin; Closure, Wound, Adhesive; Dilator, Nasal; Dressing, Wound, Hydrogel Without Drug And/Or Biologic; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Syringe, Irrigating (Non Dental) |
| Nam Ha Viet Nam Trading Company Limited | Repackager or relabeler | 3 | Non-Coring (Huber) Needle; Set, Administration, Intravascular; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Steute Technologies GmbH & Co. Kg | Contract manufacturer | 1 | Laparoscope, General & Plastic Surgery |
| Probo Medical Ltd | Foreign exporter | 16 | System, X-Ray, Tomography, Computed; System, Tomography, Computed, Emission; System, Imaging, Pulsed Doppler, Ultrasonic; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic; Cystoscope And Accessories, Flexible/Rigid; Injector And Syringe, Angiographic; Full Field Digital, System, X-Ray, Mammographic; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Bronchoscope (Flexible Or Rigid) |
| Tianjin Huahong Technology Co., Ltd. | Manufacturer | 2 | Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen |
| PRIMED Laos Medical Products Manufacturing Sole Co., Ltd. | Manufacturer | 2 | Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs; Gown, Isolation, Surgical |
| Omniscient Neurotechnology PTY Ltd (O8t) | Manufacturer | 2 | System, Image Processing, Radiological; Automated Radiological Image Processing Software |
| Gs Medical Co., Ltd. | Manufacturer | 1 | Posterior Cervical Screw System |
| Primed Medical Products Inc. | Specification developer (outsources manufacturing) | 2 | Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs; Gown, Isolation, Surgical |
| Primed Liyang Medical Products Manufacturing Co., Ltd. | Manufacturer | 2 | Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs; Gown, Isolation, Surgical |
| Gushi priMED Medical Products Manufacturing Co., Ltd. | Manufacturer | 2 | Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs; Gown, Isolation, Surgical |
| Yongkang Joymax Medical Technology Co.,Ltd | Manufacturer | 2 | Wheelchair, Powered; Walker, Mechanical |
| Hans Biomed Corp. | Manufacturer | 1 | Suture, Surgical, Absorbable, Polydioxanone |
| Guangzhou Red Pine Medical Instrument Co.,Ltd. | Manufacturer | 1 | Ureteroscope And Accessories, Flexible/Rigid |
| Zhenjiang Assure Medical Equipment Co Ltd | Manufacturer | 4 | Wheelchair, Mechanical |
| Odin Medical Limited | Manufacturer | 2 | Gastrointesinal Lesion Software Detection System; Software For Endoscopy Procedure Metrics |
| Yangzhou Aolikes Sports Goods Co., Ltd. | Manufacturer | 3 | Orthosis, Lumbar; Orthosis, Thoracic; Orthosis, Limb Brace |
| Kim Sora Corporation | Manufacturer | 1 | Mask, Surgical |
| Remidio Innovative Solutions Private Limited | Manufacturer | 1 | Camera, Ophthalmic, Ac-Powered |
| Beyes Dental Inc | Manufacturer | 3 | Point, Paper, Endodontic; File, Pulp Canal, Endodontic; Gutta-Percha |
| Brainomix Limited | Manufacturer | 1 | Automated Radiological Image Processing Software |
| Yongkang Hengyi Vehicle Co.,Ltd | Manufacturer | 1 | Wheelchair, Powered |
| Shenzhen OSTO Medical Technology Company Limited | Manufacturer | 2 | Stimulator, Muscle, Powered, For Muscle Conditioning; Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Yamaha Motor Co Ltd | Manufacturer | 1 | Wheelchair, Powered |
| Kowa Co. Ltd. Chofu | Manufacturer | 1 | Ophthalmoscope, Laser, Scanning |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Specification developer (outsources manufacturing) | 2 | Electrode, Electrocardiograph; Airway, Oropharyngeal, Anesthesiology |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Manufacturer | 1 | Endoscopic Access Overtube, Gastroenterology-Urology |
| Shenzhen Anker Medical Devices Co., Ltd. | Manufacturer | 1 | Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter |
| Spident Co., Ltd. | Manufacturer | 2 | Adhesive, Bracket And Tooth Conditioner, Resin; Resin, Root Canal Filling |
| Shandong Lianfa Medical Plastic Products Co. Ltd. | Manufacturer | 3 | Tape And Bandage, Adhesive; Bandage, Liquid, Skin Protectant; Solvent, Adhesive Tape |
| Shokz Health Global Limited | Specification developer (outsources manufacturing) | 1 | Hearing Aid, Bone Conduction |
| Duplex International Trading Limited | Manufacturer | 2 | Light Based Over The Counter Wrinkle Reduction; Over-The-Counter Powered Light Based Laser For Acne |
| Samsung Electronics Co., Ltd. | Manufacturer | 1 | System, X-Ray, Stationary |
| Samsung Electronics Co., Ltd. | Specification developer (outsources manufacturing) | 1 | System, X-Ray, Stationary |
| Digital Surgery Limited | Manufacturer | 2 | Software Controlled Endoscope And Instrument Holder; Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation |
| Beijing Orionstar Technology Co., Ltd. | Manufacturer | 1 | Wheelchair, Powered |
| Kettenbach GmbH & Co Kg | Manufacturer | 2 | Varnish, Cavity; Agent, Polishing, Abrasive, Oral Cavity |
| Wuhan Pakcare Bio-Technology Co., Ltd. | Manufacturer | 2 | Lamp, Infrared, Therapeutic Heating; Pack, Hot Or Cold, Water Circulating |
| Hironic Co., Ltd. | Manufacturer | 2 | Stimulator, Transcutaneous Electrical, Aesthetic Purposes; Brush, Dermabrasion, Powered |
| WIPRO GE HEALTHCARE PRIVATE Ltd. | Specification developer (outsources manufacturing) | 1 | System, Monitoring, Perinatal |
| Hefei Meyer Optoelectronic Technology Inc. | Manufacturer | 1 | X-Ray, Tomography, Computed, Dental |
| Anhui Kangfu Industrial Foreign Trade Co.,Ltd | Manufacturer | 5 | Exerciser, Non-Measuring; Orthosis, Lumbo-Sacral; Helmet, Cranial, For Protective Use; Orthosis, Thoracic; Exerciser, Powered |
| Filmecc Co., Ltd. | Manufacturer | 1 | Wire, Guide, Catheter |
| Asterasys Co., Ltd. | Manufacturer | 1 | Electrosurgical, Cutting & Coagulation & Accessories |
| Bioretec Ltd. | Manufacturer | 1 | Screw, Fixation, Bone |
| Denjoy Dental Co., Ltd | Manufacturer | 2 | Gutta-Percha; Endodontic Kit |
| Flexicare Medical Ltd. | Specification developer (outsources manufacturing) | 2 | Bronchoscope (Flexible Or Rigid); Cart, Emergency, Cardiopulmonary (Excluding Equipment) |
| Weifang Dragonfly Electronic Technology Co., Ltd. | Manufacturer | 1 | Arthrogram Tray |
| Beijing Mega Beauty Technology Co.,Ltd. | Manufacturer | 1 | Powered Laser Surgical Instrument |
| Guangdong Horigen Mother & Baby Products Co., Ltd. | Manufacturer | 1 | Pump, Breast, Powered |
| Shenzhen Yingchi Technology Co., Ltd. | Manufacturer | 2 | Extracranial Positional System For A Transcranial Magnetic Stimulation System; Transcranial Magnetic Stimulator |
| Hangzhou Tappa Medical Technology Co., Ltd. | Manufacturer | 1 | System, Thermal Regulating |
| Yiwu Ori-Power Medtech Co., Ltd. | Manufacturer | 2 | Sling, Arm; Mask, Surgical |
| Fisher & Paykel Healthcare, Ltd. | Manufacturer | 1 | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Joytech Healthcare Co., Ltd. | Manufacturer | 2 | System, Measurement, Blood-Pressure, Non-Invasive |
| Rens Medcare (Cambodia) Co.,Ltd. | Manufacturer | 2 | System, Measurement, Blood-Pressure, Non-Invasive |
| Siemens Shanghai, Medical Equipment Ltd. | Manufacturer | 2 | Solid State X-Ray Imager (Flat Panel/Digital Imager); System, X-Ray, Stationary |
| Custom Foam Systems, Ltd. | Manufacturer | 1 | Stretcher, Wheeled |
| Shenzhen Kesite Digital Technology Co., Ltd. | Manufacturer | 2 | Collector, Urine, Powered, Non Indwelling Catheter; Unit, Cryosurgical, Accessories |
| Hunan Accurate Bio-Medical Technology Co., Ltd. | Manufacturer | 1 | Perineometer |
| OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant | Manufacturer | 2 | Transducer, Ultrasonic, Diagnostic; Ultrasound Bronchoscope |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd | Manufacturer | 2 | Colonoscope And Accessories, Flexible/Rigid; Gastroscope And Accessories, Flexible/Rigid |
| Hangzhou Qiantang Longyue Biotechnology Co.,Ltd | Manufacturer | 2 | Set, I.V. Fluid Transfer; Needle, Hypodermic, Single Lumen |
| Huana Technology (Thailand) Co., Ltd. | Manufacturer | 2 | Catheter And Tip, Suction; Container, Liquid Medication, Graduated |
| Shanghai Wallaby Medical Technologies CO., Inc. | Manufacturer | 2 | Catheter, Percutaneous, Neurovasculature; Catheter, Percutaneous |
| Labotech Microscopes India Private Limited | Manufacturer | 2 | Colposcope (And Colpomicroscope), Exempt; Microscope, Surgical |
| Power Dental Studio Milling Pvt Ltd | Manufacturer | 2 | Restoration, Porcelain; Alloy, Metal, Base |
| Sony Corporation | Specification developer (outsources manufacturing) | 1 | Laparoscope, General & Plastic Surgery |
| T.A.G. Medical Products Corporation Ltd | Manufacturer | 1 | Screw, Fixation, Bone |
| Guangzhou Four E's Scientific Co., Ltd. | Manufacturer | 3 | Articulators; Tape And Bandage, Adhesive; Apparatus, Melting Point, Paraffin |
| Shenzhen Ziqing Medical Equipment Co., Ltd | Manufacturer | 2 | System, Measurement, Blood-Pressure, Non-Invasive |
| Jiangsu Hongsheng Bioengineering Co., Ltd. | Manufacturer | 3 | Dressing, Wound, Hydrophilic; Elastomer, Silicone, For Scar Management; Dressing, Wound, Occlusive |
| Remex Medical Corp. | Specification developer (outsources manufacturing) | 1 | Orthopedic Stereotaxic Instrument |
| Cimilre Co., Ltd. | Manufacturer | 1 | Pump, Breast, Powered |
| Zeros Co., Ltd. | Manufacturer | 2 | Implant, Endosseous, Root-Form; Abutment, Implant, Dental, Endosseous |
| Bonalive Ltd | Manufacturer | 1 | Bone Grafting Material, Synthetic |
| Guangzhou Heygears Imc.Inc | Specification developer (outsources manufacturing) | 1 | Resin, Denture, Relining, Repairing, Rebasing |
| Taizhou Padeng Glasses Co., Ltd. | Manufacturer | 5 | Lens, Spectacle, Non-Custom (Prescription); Frame, Spectacle; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Spectacle, Magnifying; Sunglasses (Non-Prescription Including Photosensitive) |
| Gemss Healthcare Co., Ltd. | Manufacturer | 1 | System, X-Ray, Mobile |
| Gi View Ltd. | Manufacturer | 2 | Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Colonoscope And Accessories, Flexible/Rigid |
| Phu Bao Medical Co., Ltd | Manufacturer | 2 | Mask, Surgical; Non-Surgical Gown |
| The Surgical Company International B.V. | Specification developer (outsources manufacturing) | 1 | System, Thermal Regulating |
| Weifang Keepbetter Healthcare Co., Ltd. | Manufacturer | 5 | Garment, Protective, For Incontinence; Cover, Mattress (Medical Purposes); Disinfectant, Medical Devices; Pad, Menstrual, Unscented; Fiber, Medical, Absorbent |
| Plastic Electromechanic Company Medical Device | Manufacturer | 2 | Spirometer, Therapeutic (Incentive) |
| Oscor Caribe LLC | Manufacturer | 1 | Introducer, Catheter |
| KARDIUM Inc. | Specification developer (outsources manufacturing) | 1 | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Hubei Yjt Intelligent Technology Group Co., Ltd. | Manufacturer | 1 | Laser, Comb, Hair |
| Momentis Surgical Ltd. | Manufacturer | 1 | Modular Electromechanical Surgical System |
| Scivita Medical Technology Co., Ltd. | Manufacturer | 1 | Ureteroscope And Accessories, Flexible/Rigid |
| Shenzhen Goodwind Technology Development CO., LTD | Manufacturer | 1 | Light Based Over The Counter Wrinkle Reduction |
| Shenzhen Leshang Technology Design Co., Ltd. | Manufacturer | 4 | Lens, Spectacle, Non-Custom (Prescription); Spectacle, Magnifying; Frame, Spectacle; Sunglasses (Non-Prescription Including Photosensitive) |
| T&R Biofab Co.,Ltd. | Manufacturer | 1 | Methyl Methacrylate For Cranioplasty |
| FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji | Specification developer (outsources manufacturing) | 1 | Transducer, Ultrasonic, Diagnostic |
| Dong Guan City Good Health Electronic Technology Co.,Ltd. | Manufacturer | 1 | Clinical Electronic Thermometer |
| Okamoto Rubber Products Co., Ltd. | Manufacturer | 1 | Condom |
| ConvaTec Limited, GDC Building | Specification developer (outsources manufacturing) | 2 | Catheter, Straight |
| Shenzhen Jianchao Intelligent Technology Co., Ltd. | Manufacturer | 1 | Light Based Over-The-Counter Hair Removal |
| Tianjin Mastervision Technology Co., Ltd. | Manufacturer | 1 | Lens, Contact, Orthokeratology, Overnight |
| Signifier Medical Technologies Limited | Manufacturer | 1 | Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea |
| Shenzhen Qinglai Innovative Intelligent Technology Co., Ltd. | Manufacturer | 3 | Sunglasses (Non-Prescription Including Photosensitive); Frame, Spectacle; Lens, Spectacle, Non-Custom (Prescription) |
| Guangdong Kelihuan Biotechnology Co., Ltd. | Manufacturer | 5 | Applicator, Ent; Cushion, Earphone (For Audiometric Testing); Pad, Eye; Applicator, Absorbent Tipped, Non-Sterile; Nasal Spray, Ent Delivery |
| Zhuhai Zorosy Technology Co., Ltd. | Manufacturer | 2 | Hearing Aid, Air-Conduction With Wireless Technology, Prescription; Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter |
| Hefei Baoguo Information Technology Co., Ltd | Specification developer (outsources manufacturing) | 12 | Orthosis, Limb Brace; Adaptor, Recreational; Board, Lap, Wheelchair; Adaptor, Hygiene; Massager, Therapeutic, Manual; Pack, Hot Or Cold, Reusable; Cushion, Wheelchair; Bedding, Disposable, Medical; Orthosis, Truncal/Orthosis, Limb; Protector, Skin Pressure |
| Shenzhen Upnmed Equipment Co., Ltd. | Manufacturer | 1 | Oximeter |
| Beijing Huacheng Taike Technology Co., Ltd. | Manufacturer | 2 | Powered Laser Surgical Instrument |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd | Manufacturer | 4 | Syringe, Periodontic, Endodontic, Irrigating; Dispenser, Solid Medication; Holder, Ureteral Catheter; Unit, Syringe, Air And/Or Water |
| See-Mode Technologies PTY Ltd | Manufacturer | 2 | Automated Radiological Image Processing Software; Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| I-SMART Development LTD. | Specification developer (outsources manufacturing) | 1 | Light Based Over The Counter Wrinkle Reduction |
| Lab Fish Equipment (Zhejiang) Co,,Ltd, | Manufacturer | 2 | Lamp, Infrared, Therapeutic Heating; Pipette, Quantitative, Hematology |
| Dyne Medical Group Inc. | Manufacturer | 1 | Endoscope Channel Accessory |
| Unimax Medical Systems Inc. | Specification developer (outsources manufacturing) | 1 | Catheter And Tip, Suction |
| Unimax Medical Systems Inc. | Manufacturer | 1 | Catheter And Tip, Suction |
| Navbit PTY Ltd | Manufacturer | 2 | Orthopedic Stereotaxic Instrument; System, Image Processing, Radiological |
| Privapath Diagnostics Ltd | Manufacturer | 1 | Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay |
| Ortho Solutions UK Limited | Specification developer (outsources manufacturing) | 1 | Rod, Fixation, Intramedullary And Accessories |
| Gimbo Medical Technology Shenzhen Co., Ltd. | Manufacturer | 1 | Needle, Assisted Reproduction |
| Madhi Corporation | Manufacturer | 3 | Retractor; Tube, Ear Suction; Curette, Surgical, General Use |
| Philips Global Business Services LLP | Manufacturer | 2 | Coil, Magnetic Resonance, Specialty |
| Bluewind Medical Ltd. | Specification developer (outsources manufacturing) | 1 | Implanted Tibial Electrical Urinary Continence Device |
| Changzhou Dsb Medical Co., Ltd | Manufacturer | 1 | Collector, Urine, (And Accessories) For Indwelling Catheter |
| Andon Health Co., Ltd | Manufacturer | 1 | Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter |
| Rayence Co., Ltd. | Manufacturer | 2 | Solid State X-Ray Imager (Flat Panel/Digital Imager); System, X-Ray, Fluoroscopic, Image-Intensified |
| Gaush Neotech Ltd. | Manufacturer | 1 | Biomicroscope, Slit-Lamp, Ac-Powered, Exempt |
| Align Technology, Ltd. | Manufacturer | 1 | Light Transmission Caries Detector |
| Augmedics Ltd. | Manufacturer | 1 | Orthopedic Augmented Reality |
| Jiangsu Optimum Optics Co., Ltd. | Manufacturer | 4 | Lens, Spectacle, Non-Custom (Prescription); Sunglasses (Non-Prescription Including Photosensitive); Lens, Spectacle (Prescription), For Reading Discomfort; Frame, Spectacle |
| Guangzhou Daxin Health Technology (Dongguan) Co., Ltd | Manufacturer | 1 | System, Measurement, Blood-Pressure, Non-Invasive |
| Shenzhen Ainengke Electronics Co, Ltd | Manufacturer | 2 | Scaler, Ultrasonic; Toothbrush, Ionic, Battery-Powered |
| Yongkang Ruihe Metal Products Co.,Ltd | Manufacturer | 2 | Vehicle, Motorized 3-Wheeled; Wheelchair, Powered |
| Singular Health PTY Ltd | Manufacturer | 1 | System, Image Processing, Radiological |
| Wenzhou Ezekiel Creative Electronic Technology Co., Ltd. | Manufacturer | 4 | Toothbrush, Powered; Massager, Therapeutic, Electric; Motor, Surgical Instrument, Pneumatic Powered; Unit, Oral Irrigation |
| Shenzhen Besdata Technology Co.,Ltd | Manufacturer | 1 | Intraoral Camera |
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