Best ISO 13485 Certified Companies Suppliers
Discover a curated list of ISO 13485 certified companies specializing in medical device manufacturing and quality assurance, ensuring compliance with industry standards for global sourcing.
ISO 13485Medical DevicesQuality AssuranceComplianceManufacturing
Omnica Corporation
🇺🇸 United States
198411-50 peopleManufacturer/Service CompanyEstablished brand
ODM manufacturer
Product customization
Multinational enterprise
Key customer
ABBOTT MOLECULAR
Key market
North America
Description
Omnica Corporation, now a part of StarFish Medical, is a premier medical device design and engineering firm headquartered in Irvine, California. Founded in 1984, the company operates from a 25,000-square-foot facility equipped with advanced in-house machining, model making, and rapid prototyping capabilities. As a contract manufacturer and service provider, Omnica specializes in the end-to-end development of complex medical technologies, including diagnostic products, surgical instruments, point-of-care devices, and monitoring equipment. Their multidisciplinary team of experts provides comprehensive services across industrial design, mechanical and electronics engineering, software development, and regulatory affairs consulting. Holding ISO 13485 and FDA certifications, the company supports a diverse clientele ranging from early-stage startups to global MedTech leaders like Medtronic and Abbott. By integrating with StarFish Medical, Omnica leverages expanded North American resources to deliver specialized R&D, feasibility studies, and seamless transitions to manufacturing for high-technology medical products.
Medical Device Design & Development
Medical Device Manufacturing Support
Surgical & therapeutic systems
Surgical & therapeutic systems
Hochuen Medical Technology Co., Ltd.
🇨🇳 China
2015501-1000 peopleManufacturer/Trading CompanyHigh capacity factory
OEM manufacturer
ODM manufacturer
Product customization
Shipments
73
Key customer
TASSO
Key market
🇺🇸 United States
Description
Hochuen Medical Technology Co., Ltd. is a leading global OEM, ODM, and CDMO manufacturer specializing in medical disposables and devices for the life sciences, IVD, and drug delivery sectors. Headquartered in Shenzhen, China, with a significant international presence including offices in Los Angeles and Singapore, the company operates advanced manufacturing facilities in Malaysia and China. With a workforce of 501 to 1,000 employees, Hochuen provides end-to-end turnkey services ranging from R&D and rapid prototyping to high-volume production. Their extensive technical capabilities include precision injection molding, microfluidic chip fabrication, die-cutting, CNC machining, and specialized bonding techniques such as laser and ultrasonic welding. The company is well-equipped for complex medical manufacturing, featuring Class 10K-100K cleanrooms and GMP-compliant facilities. Their product portfolio encompasses biomedical consumables, medical wearables, biosensors, and reagent packaging. Hochuen Medical is FDA registered and holds ISO 13485, ISO 14001, and GMP certifications, serving over 250 global clients including major industry leaders in diagnostics and medical technology.
Custom Die Cutting Self Adhesive EVA Foam Gasket for Medical Use$0.02
Qinhuangdao Huisianpu Medical Systems Inc.
🇨🇳 China
2011101-200 peopleManufacturer/Trading CompanyOEM manufacturer
ODM manufacturer
Product customization
Patented technology
Shipments
7
Key customer
WELLTEC
Key market
🇩🇪 Germany
Review
2.4
Best Choice Professional Medical Devices Optimal Magnetic Therapy Physical Therapy Machine for Medical Treatment$900
Professional Medical Devices for Rehabilitation and Physical Therapy Quality Guaranteed for Bone Improvement on Sale$900
Pulse Magnetic Infrared Therapy Device for Microcirculation Repair Physical Therapy Equipment for Body Leg PMR Medical Equipment$900
FDA-Certified Home Use PEMF Mat Certified Household Medical Device for Pain Relief Sleep & Detox Magnetic Therapy Device$450
Portable Medical Grade PEMF Therapy Device Exclusive System Physical Therapy Equipment for Joint Pain Relief and Improved Sleep$249
No Side Effect Pemf Magnetic Therapy Device Sleep Aid for Hand Lower Limbs Arthritis Physiotherapy Physical Therapy Equipment$900
2025 Portable High Potential Therapy Machine for Constipation Effective Physical Therapy Equipment$900
Factory Manufacture Anti-Aging Physiotherapy Rehabilitation Equipment Imported Curing Neck Pain Physical Therapy Gear$500
Large-Capacity 90-Litre Pet Dryer Pulsed Electromagnetic Field (PEMF) Therapy Intelligent Temperature Veterinary Instrument$200
AM6200 Pet Monitor One-Button Operation Measures ECG Heart Rate Non-Invasive Blood Pressure Blood Oxygen Saturation Pulse Rate$260
Hot Sale Portable Home Physiotherapy Equipment Top Physical Therapy Gear for Effective Joint Pain Relief$249
Home Painless Veterinary Instrument Magnetic Therapy Equipment for Pets Immunity & Gastrointestinal Conditioning$500
Jiangsu Qianjing Medical Equipment Co., Ltd.
🇨🇳 China
2002201-300 peopleManufacturer/Trading CompanyEstablished brand
OEM manufacturer
Own brand
Product customization
Shipments
456
Key customer
PRAECISO SOLUTIONS
Key market
🇮🇳 India
Review
4.9
Medical Disposable Skin Stapler$1.5
Disposable Circumcision Stapler Suture Device$15
Disposable Linear Cutter Stapler and Loading Units$50
Top Quality Stapler Circumcision Phimosis Treatment Circumcision Surgery$15
Male Circumcision Stapler Kit for Adults$15
Factory Skin Stapler Staples Disposable Skin Stapler and Surgical Staples for Surgical$1.5
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Compare suppliers based on factors such as product quality, pricing, certifications, production capacity, lead times, export experience, and communication responsiveness. Evaluating suppliers against the same criteria makes decision-making more objective.
Shenzhen Hochuen Technologies Co., Ltd.
🇨🇳 China
20042001-5000 peopleManufacturer/Trading CompanyHigh capacity factory
Established brand
Large enterprise group
OEM manufacturer
Shipments
51
Key customer
EURO CB PHILS
Key market
🇵🇠Philippines
Review
5
High Quality Medical Device Contract Manufacturing Product Development Service Custom Two Shot Injection Molding Medical$0.99
Customization Wholesale Strong Adhesion Acrylic Clear Medical Tape Die Cut Foam Tape for Medical Device$0.05
ISO13485 Medical Device Cleanroom Manufacturing Factory Custom Thickness OEM Colored Double Sided Coated Adhesive Foam Tape$0.1
Custom Self-Adhesive Industrial PET Biochip Control Panel Sticker Decals Medical Device Labels Processing Service Cutting$0.2
Custom Silicone Rubber Pad Graphic Overlay Adhesive Keyboard Embossed Button Sticker Membrane Switch Keypad for Medical Device$0.02
ISO13485 Cleanroom Die Cut Insulation Pad Adhesive Tapes Two Side Polyurethane Polyomide 2mm Thick Foam Tape for Medical Device$0.2
Medical Device CDMO Manufacturing Plastic Products Test Kit ABS PC PP Injection Molding for IVD and POCT Test Cartridge$0.02
Tamper-Evident Anti-Counterfeiting Security Stickers High-Visibility Warning Industrial Labels Certified Medical Label$0.02
OEM Medical Product PSA Strong Adhesives 3M Custom Die Cutting Round 9448A Electricity Adhesive Masking Tape$0.05
High Quality Removable Adhesive Tape Sticker Customized Fingerboard Medical Self Adhesive Foam Insulation Tape for Automotive$0.02
Medical Parts Moulding Factory Plastic Parts Machining Components Diffusion Bonding Assembly Microfluidic Chip for IVD Products$0.05
Custom Die Cut Medical Products Different Shape 3M Double Adhesive Sided Foam Tape for Cushioned Foam Shockproof$0.05
Foshan Hongke Medical Instrument Factory
🇨🇳 China
200451-100 peopleManufacturer/Trading CompanyEstablished brand
Own brand
Low MOQ
Industry association member
Shipments
281
Key customer
BESTODENT
Key market
🇮🇳 India
Review
4.2
2023 new classic professional medical devices Hongke medical dental chair$1000
Economical Dental Chair Many Dentist Choice Professional Medical Devices Hongke RS1$860
2022 Cheap Dental Chair Units with High Quality Dental Chair$840
One-stop supplier full set dentist chair dental unit with double light source inductive oral lamp$1000
Factory hot sale comfortable hospital dental equipment oral observation integral dental unit$1000
Hot popular chairs dental unit secure design premium safety multifunctional electric dental chair$1200
Foshan HONGKE Siger Dental Unit Chair Spare Parts Dental Equipment$1188
dental tools instruments dental handpiece china$25
2023 Modern Safety Dental Equipment Multifunction Best Oral Implant Dental Chair$1200
dental handpiece 4hole dental tools instruments$25
CE Approved Dental Implant Machine Used Dental Chair$1450
Ningbo Five Continents Medical Instrument Co., Ltd.
🇨🇳 China
200451-100 peopleManufacturer/Trading CompanyEstablished brand
OEM manufacturer
ODM manufacturer
Low MOQ
Shipments
26
Key customer
MERIL HEALTHCARE
Key market
🇪🇪 Estonia
Review
4.9
Surgical Device Disposable Electrosurgical Medical Blue Esu Pencil$0.5
Innovative Disposable Wound Irrigator Arthroplasty Medical Device Technology$21
Qualified Medical Care Device Finger Splint Orthopedic Splint$0.5
Disposable Surgical Lavage C Wound Cleaner Arthroplasty Medical Device$21
Customized Esu Medical Cables Disposable Surgical Pen Health Medical High Quality Sterilized Disposable Electrosurgical Pencil$0.6
Medical Device Pulse Lavage in Arthroplasty Surgery and Truma Cases$10
Medical Equipment Esu Pencil Surgical Instrument$0.5
Disposable Pulse Lavage System Surgical Wound Cleaner Arthroplasty Medical Device Fast$21
High Frequency Medical Devices Diathermy Pencil Manual Unipolar Electrodes Electrosurgical Pencil$0.5
Disposable Pulse Lavage System Irrigator Surgical Wound Cleaner Arthroplasty Medical Device$21
Disposable Surgical Lavage System Irrigation Device Wound Cleaner Arthroplasty Medical Device Fast$21
Medical Multi-Functional Orthopedic Arthroscopy Shaver Blade$23
Kernel Medical Equipment Co., Ltd
🇨🇳 China
1997501-1000 peopleManufacturer/Trading CompanyHigh capacity factory
Established brand
OEM manufacturer
ODM manufacturer
Shipments
388
Key customer
DOLPHIN
Key market
🇮🇳 India
Review
4.8
KN-9000B Medical Woods Lamp Skin Analysis Medical Dermatology Device$249
Professional Kernel Medical LED Photodynamic Therapy Device KN-7000D with Medical CE TGA$3500
KN-9000B Medical Magnifier Woods Lamp Skin Analysis Medical Dermatology Examination Device Wood's Lamp$249
Professional Medical CE Approved Digital 4k Colposcope Video Vaginal Medical Colposcope Device for Gynecology$2300
For Kernel Medical Equipment's Effective Phototherapy Ultraviolet Rays Treatment for Vitiligo Household Medical Device$210
Professional KN-5000C Medical Equipment 308 Excimer Laser Machine for Psoriasis Vitiligo Treatment Clinic Medical Device$1800
Dermatology Beauty Device Wood Lamp Portable Dialysis Machine medical Skin Analyzer Facial medical woods lamp KN-9000c$99
Dermatology Beauty Device Wood Lamp Portable Dialysis Machine Medical Skin Analyzer Facial Medical Woods Lamp KN-9000c$99
Class IIa Medical Devices Medically CE LED Light Therapy Facial Certified for Acne, Psoriasis, Wound Healing KN-7000A$4580
Hair Growth System LED Therapy for Scalp Care Professional Medical LED Light Therapy Device Medical PDT Red Blue Yellow Infrared$4580
Kernel Medical Grade Red Light Therapy Device 4 LED Therapy Brightness Adjustable High Power Medical Grade PDT Machine for Skin$3500
Kernel Medical Digital Equipment Coloposcope CE Medical Video Camera Colposcope for Gynecology Vaginal Examination$2300
Hangzhou Hua'an Medical & Health Instruments Co., Ltd.
🇨🇳 China
1997201-300 peopleManufacturer/Trading Company/Wholesaler/DistributorEstablished brand
OEM manufacturer
ODM manufacturer
Product customization
Shipments
81
Key customer
ESSEF DISTRIBUTION
Key market
🇺🇸 United States
Review
4.5
Huaan Med Other Household Medical Devices Body Medical Temperature Measurement Digital Thermometer$0.5
DT-111B Medical Devices Digital Thermometer for Fever Monitoring$0.8
HUA'AN MED Household Medical Devices Fever Termometro Baby Digital Flexible Thermometer$0.63
Fast Dispatch Medical Supplies Clinical Baby Basal Oral Mouth Rectal Armpit Digital Termometro Thermometers$0.4
HUAAN Medical Tensiometro Pressure Checking Blood Pressure Monitor Upper Arm Aneroid Sphygmomanometer With Stethoscope$6.68
HUA'AN MED Fast Accuracy Oral Rectal Armpit Fever Body Clinical Medical Digital Flexible Thermometer$0.83
HUAAN Medical Tensiometro Checking Manual Blood Pressure Monitor Upper Arm Aneroid Sphygmomanometer With Sprague Stethoscope$6.68
Economical Cuff Medical Supplies Electronic Wrist Band Tensiometro BP Digital Blood Pressure Sphygmomanometer Machine Monitor$4.99
All in PINK Medical Tensiometro Pressure Checking Blood Pressure Monitor Upper Arm Aneroid Sphygmomanometer With Stethoscope$6.68
Display Voice Prompt Cuff Medical Supplies Electronic Price Upper Arm BP Digital Blood Pressure Sphygmomanometer Machine Monitor$5.15
Top Quality Trending Products New Arrivals Medical Supplies Clinical Glass Gallium Oral Mouth Rectal Armpit Digital Thermometers$1.2
HUAAN NEWEST Flexible Tip Ovulation Oral Armpit Children Kids Baby Adult Medical Clinical Electronic Fever Digital Thermometers$0.75
Viet Ba Equipment Company Limited
🇻🇳 Vietnam
199911-50 peopleTrading Company/Service CompanyEstablished brand
Industry association member
High-tech enterprise
Experienced exporter
Shipments
2657
Key customer
NVC
Key market
🇻🇳 Vietnam
Description
Viet Ba Equipment Company Limited is a specialized medical technology provider based in Hanoi, Vietnam. Established in 1999, the company operates as a trading and service entity with a focus on high-tech medical equipment and integrated healthcare IT solutions. The organization maintains a workforce of 11 to 50 employees and holds prestigious quality management certifications, including ISO 9001:2015 and ISO 13485:2016 for medical devices.
The company's extensive product portfolio covers diagnostic imaging and laboratory diagnostics. Key offerings include diagnostic X-ray systems, CT scanners, digital X-ray detectors, endoscopy and ultrasound equipment, and medical display units. Their laboratory division provides automatic biochemistry, hematology, immunology, and coagulation analyzers, alongside electrolyte blood gas and urine analysis systems. Beyond hardware, the company is a recognized developer of specialized software solutions, including Hospital Information Systems (HISLink), Laboratory Information Systems (LABLink), and Radiology Information Systems (RISLink/PACS).
Viet Ba Equipment Company Limited engages in international trade, importing advanced components and diagnostic sets from suppliers in Japan, South Korea, India, and China to support the Vietnamese healthcare market. With over two decades of experience, the company has been recognized with multiple national awards for its contributions to science and technology in the medical field.
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