Which medical device

For now there is 6 products that are listed:. Cosmetic contact lenses to change color of the eye will now be considered Medical Devices. I suppose that they talk about cosmetic implants, or even trackers that are implanted on the hand to see where you are located or for you to open doors… Maybe.

It is focused on Botox or Hyaluronic Acid. This is injected under the skin to look younger but it should have no physiological or metabolic action. Have you ever seen those new devices with light pulsed that are used to remove hair. Even equipment for sunbathing would be included. This is the future and we are their. Do you imagine those equipment that can help us to sleep or that can interact with our brain… This is cool no.

They are now medical devices. If you plan to manufacture or sell one of these products in future, I would recommend to learn more on Medical Devices as your business will be at risk.

If you are located in European Union, you should already have a Notified Body that can help you to identify your product. One of them is to identify an Authorized Representative. Even with all the definition possible, there are some cases that are still at the border of every regulation. This is a document that is regularly updated and offers also some advice on some products.

This last class is also new. Particularly cleaning, disinfection, sterilization, maintenance and functional testing and the related instruction for use of it. This can also be critical so you need to learn more on this as there will be more and more. Learn more. To help you on your learning journey on the classification of EU Medical Devices you can also have a look at this post. The new Medical Device Regulation is also making some changes to some products that change their classification.

So more requirements for some orthopedic companies. I think you have made enough progress on the European Union Regulation. On the webpage, there are all the places where it is available. It helps to make a distinction with all the other products regulated by FDA such as drug.

Here is the extract that you can find at this address: LINK. Ok, here I have some comments to make. We can see that there is a major difference between the EU and US medical device definition. So veterinary products and Human products are considered similar. If you run a veterinary business in Europe, you should be careful regarding the requirements as its different than what you would expect.

Each of those classes do need a different way to put the product on the market. If you are located in USA, this could be simple. FDA is having a website where they display a database with all products registered and their classification. Here are some examples from this site:. The definition of Medical Device is:. Medical product: healthcare product, such as equipment, devices, materials, articles, or systems for medical, odontological, or laboratory use or application, intended for prevention, diagnosis, treatment, rehabilitation, or anti-conception and that does not use pharmacological, immunological, or metabolic means to fulfill its main function in human beings, but can have its functions assisted by such means.

Obviously, it looks not so different than the other countries. This definition is shorter but includes all the specificity of a Medical Device. It also includes the distinction with a borderline product Medical Device or Pharmaceutical. Here is the official CFDA medical devices definition. Check the website CFDA website :. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:.

The vocabulary used is the same as for the European Union. It also is specific to Humans. Logically, the definition of medical devices is in majority similar in most of the main countries. However, there are also differences. And only the United States are considering veterinary products on the definition of Medical Devices. But, even with all this, there is still some problems. You will see if you are dealing with some health authorities. The agents are using some exotic interpretation from the definitions.

It helps the manufacturers and the health authorities to speak the same language and provide the best support to Patients. Because the intended use was not specifically matching the definition. But when you look at those device, for sure they should be considered as medical devices. I hope this article helped you to enter the world of Medical Devices. I am sure you still have a lot of questions and I will continue to create more articles to answer them.

Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. CooperVision offers soft contact lenses for the vision-correction market. CooperSurgical offers an array of products and services focused on advancing the health of families through a portfolio of products and services geared towards women's health, fertility, and diagnostics.

CooperVision develops, manufactures, and markets a range of single-use, two-week, and monthly contact lenses, featuring various materials and optics.

CooperVision's products are designed to solve vision challenges, such as astigmatism, presbyopia, ocular dryness, and eye fatigue, with a collection of spherical, toric, and multifocal contact lenses. Teleflex Inc. The company primarily designs, develops, manufactures, and supplies single-use medical devices used by hospitals and health care providers for common diagnostic and therapeutic procedures in critical care and surgical applications. Cardinal Health offers distribution, inventory management, data reporting, new product launch support, and charge-back administration services to pharmaceutical manufacturers; pharmacy and medication therapy management, and patient outcomes services to hospitals, other health care providers, and payers; and consulting, patient support, and other services to pharmaceutical manufacturers and health care providers.

Cardinal Health Inc. Straumann conducts research with leading universities, and manufactures dental implants and a host of other products in the dental industry. Steris PLC provides infection prevention and other procedural products and services. The company operates through four segments: health care products, which offers infection prevention and procedural solutions for health care providers, including capital equipment and related maintenance, installation services, and consumables; health care specialty services, which provides a range of specialty services for health care providers, including hospital sterilization services, instrument and scope repairs, and linen management; Life Sciences, which offers capital equipment and consumable products, and equipment maintenance and specialty services for pharmaceutical manufacturers and research facilities; and Applied Sterilization Technologies, which offers contract sterilization and laboratory services for medical device and pharmaceutical customers and others.

Hologic Inc. The company sells and services its products through a combination of direct sales and service personnel and a network of independent distributors and sales representatives. Waters Corp. Specifically, the company designs, manufactures, sells, and services ultra-performance liquid chromatography UPLC , high-performance liquid chromatography HPLC , chromatography columns and chemistry products, mass spectrometry MS systems, thermal analysis, and rheometry instruments.

West Pharmaceutical Services Inc. The company's products include vial containment solutions, prefillable systems, self-injection platforms, cartridge systems and components, reconstitution and transfer systems, intradermal delivery solutions, specialty components, and contract manufacturing and analytical services.

Varian Medical Systems Inc. Its VPT business develops, designs, manufactures, sells, and services products and systems for delivering proton therapy, another form of external beam radiotherapy using proton beams for the treatment of cancer. The company develops, manufactures, and markets solutions like dental and oral health products, as well as other consumable medical devices. The company operates through two segments: dental and health care consumables, and medical technology.

The dental industry encompasses the diagnosis, treatment, and prevention of disease and ailments of the teeth, gums, and supporting bone. The company's principal dental product categories are dental consumable products, dental laboratory products, dental specialty products, and dental equipment.

Additionally, the company's consumable medical device products are used for urological and surgical applications. Masimo Corporation, incorporated on May 7, , is a medical technology company that develops, manufactures, and markets a range of noninvasive patient-monitoring technologies. The company's business is measure-through motion and low perfusion pulse oximetry monitoring, known as Masimo Signal Extraction Technology SET pulse oximetry.

Its product offerings include noninvasive monitoring of blood constituents with an optical signature, optical organ oximetry monitoring, and more.

Sartorius Stedim Biotech SA is a German-based international provider of laboratory and process technologies and equipment. The company covers the segments of biotechnology and mechatronics. Sartorius provides services that help customers implement complex and quality-critical processes in biopharmaceutical production and laboratory environments in a time- and cost-efficient way. Sartorius operates its own production facilities in Europe, Asia, and America and also has sales offices and local representatives in more than countries.

The company's segments include New Zealand, which includes all activities controlled by entities or employees based in New Zealand; North America, which includes all activities controlled by entities or employees based in the United States and Canada; Europe, which includes all activities controlled by entities or employees based in the United Kingdom, France, Germany, Sweden, Turkey, and Russia; and Asia-Pacific, which includes all activities controlled by entities or employees based in Australia, Japan, India, China, South Korea, Taiwan, and Hong Kong.

Its products include respiratory humidifiers, single-use and reusable chambers and breathing circuits, infant resuscitators, infant warmers, and accessories. In addition, the company offers hardware and consumables.

Cochlear Limited is engaged in providing implantable hearing solutions. The company's implant systems comprise an implant, which is inserted during surgery, and an external sound processor. The company sells its products in over countries. CEO, chairman, and president Michael R. Asahi Intecc Co. The company specializes in making ultrafine stainless steel ropes for use in catheter treatment. The company also manufactures products for cardiovascular treatments.

The company is headquartered in Nagoya and has six branches worldwide. Hill-Rom Holdings Inc. The company partners with health care providers across care settings by focusing on patient care solutions that improve clinical and economic outcomes in five core areas: advancing mobility; wound care and prevention; patient monitoring and diagnostics; surgical safety and efficiency; and respiratory health.

Amplifon SpA is an Italy-based company engaged in the hearing systems industry. It distributes, adjusts, and personalizes hearing aids. They are able to meet needs because they address a wide range of problems stemming from slight to serious hearing loss.

The hearing aids ensure that listening quality is consistent as they adapt to different sound environments. Haemonetics Corporation, incorporated on August 29, , is a health care company. The company provides various products to customers involved in the processing, handling, and analysis of blood.

It provides plasma collection systems and software, enabling plasma fractionators to make pharmaceuticals. It provides analytical devices for measuring hemostasis, which enable health care providers to manage their patients' bleeding risk. Haemonetics makes blood processing systems and software, which tracks blood components. The company sells products under brands Jierui and Wego Ortho. The company operates through three business segments. The Single-Use Medical Device Products segment is engaged in the production and sale of single-use consumables, such as infusion sets, syringes, blood transfusion sets, and blood bags.

The Orthopedic Products segment is engaged in the production and sale of orthopedic products. The Blood Purification Products segment is engaged in the production and sale of blood purification products and related medical equipment. Insulet Corporation, incorporated on July 20, , is engaged in the development, manufacture, and sale of the Omnipod Insulin Management System the Omnipod System , an insulin delivery system for people with insulin-dependent diabetes.

The Omnipod System eliminates the need for a bulky pump, tubing, and separate blood glucose meter; provide for virtually pain-free automated cannula insertion; communicate wirelessly; and integrate a blood glucose meter.

Globus Medical Inc. The company is focused on developing products for patients with musculoskeletal disorders. It is focused on products to treat patients with spine disorders. The company's products fall under categories including Innovative Fusion and Disruptive Technologies. The products in the Innovative Fusion category include fusion products to treat spinal disorders for the entire spine, and they can be used in various surgical approaches.

The Disruptive Technologies category represents a shift in the treatment of spinal disorders by allowing for surgical procedures and the treatment of spinal disorders. Getinge AB is a global medical technology company, founded in Sweden in The firm provides equipment and systems within health care and life sciences. Getinge is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within health care and life sciences.

The company was organized into three distinct business areas: Infection Control Getinge , Extended Care ArjoHuntleigh and Medical Systems Maquet , but it was announced in March that the company would unify its brands under the Getinge name moving forward. Tandem Diabetes Care Inc. The company is engaged in designing, developing, and commercializing products for people with insulin-dependent diabetes.

The company manufactures and sells more than three insulin pump products in the United States that are designed to address the insulin-dependent diabetes market, which include t:slim Insulin Delivery System t:slim , t:flex Insulin Delivery System t:flex , and t:slim G4 Insulin Delivery System t:slim G4. The company's technology platform features Micro-Delivery Technology, a miniaturized pumping mechanism that draws insulin from a flexible bag within the pump's cartridge rather than relying on a syringe-and-plunger mechanism.

Integra LifeSciences Holdings Corporation, incorporated on June 19, , is a medical technology company. The company focuses on the development, manufacturing, and marketing of surgical implants and medical instruments. The company's products are used in neurosurgery, extremity reconstruction, orthopedics, and general surgery. Inogen Inc. It offers Inogen One, a portable device that concentrates the air around the patient to provide a single source of supplemental oxygen; Inogen At Home stationary oxygen concentrators; and related accessories.

Nevro Corp. The company focuses on providing products that improve the quality of life of patients suffering from chronic pain.

The company has developed and commercialized the Senza spinal cord stimulation SCS system, an evidence-based neuromodulation platform for the treatment of chronic pain. The company's HF10 therapy is designed to deliver neuromodulation solutions for treating chronic pain.

HF10 therapy enables patients to achieve sustained pain relief without paresthesia, thus enabling patients to avoid the uncomfortable shocking or jolting sensations commonly associated with paresthesia.

ICU Medical Inc. The company's product line includes needle-free connection devices; custom infusion sets; closed-system transfer devices CSTD for the handling of hazardous drugs; advanced sensor catheters; needle-free closed blood sampling systems; disposable pressure transducer systems; and hemodynamic monitoring systems. As of December 31, , its products were used in acute care hospitals and ambulatory clinics in more than 65 countries throughout the world.

Wright Medical Group N. As of , the company markets hundreds of products in over 50 countries worldwide. Wright Medical Group makes biologics and sport medicine products, as well as products for upper and lower extremities. Wright Medical Group acquired Cartiva Inc. MicroPort Scientific Corporation is a Hong Kong-based investment holding company principally engaged in the manufacture and sale of medical products.

The company operates through seven segments. The Orthopedics Devices segment researches, develops, manufactures, and sells orthopedics devices.

The Cardiovascular Devices segment researches, develops, manufactures, and sells cardiovascular devices, such as drug-eluting stents. The Endovascular Devices segment researches, develops, manufactures, and sells endovascular devices. The Electrophysiology Devices segment researches, develops, manufactures, and sells electrophysiology devices.

The Neurovascular Devices segment researches, develops, manufactures, and sells neurovascular devices. The Surgical Management segment researches, develops, manufactures, and sells surgical devices. The Diabetes Care and Endocrine Management segment researches, develops, manufactures, and sells devices related to diabetes mellitus.

NuVasive Inc. The company focuses on developing minimally disruptive surgical products and procedurally integrated solutions for spine surgery. The company's product portfolio focuses on applications for spinal-fusion surgery, including biologics used to aid in the spinal-fusion process. The company's principal product offering includes a minimally disruptive surgical platform called Maximum Access Surgery MAS.

The company is, engaged on a global basis, in the development, manufacture, and sale of surgical devices and related equipment. The company provides surgical devices and equipment for minimally invasive procedures.

The company's products are used by surgeons and physicians in a range of specialties, including orthopedics, general surgery, gynecology, neurosurgery, and gastroenterology. The company's product lines consist of orthopedic surgery, general surgery, and surgical visualization. The company's products are distributed domestically directly to thousands of hospitals, surgery centers, and other health care institutions, as well as through medical specialty distributors.

Gerresheimer AG is a Germany-based company that is active in the pharmaceuticals and health care industries. The company operates through two business segments: Plastics and Devices, and Primary Packaging Glass. The Plastics and Devices segment produces standard and customized products for drug delivery, such as insulin pens, inhalers, and prefillable syringes.

The Primary Packaging Glass segment focuses on the production of packaging of glass for medicines and cosmetics, such as pharmaceutical jars, ampoules, injection vials, cartridges, perfume flacons, and cream jars, as well as glass containers for the food and beverage industry. Merit Medical Systems Inc. The company operates in two segments: cardiovascular and endoscopy. The cardiovascular segment consists of cardiology and radiology devices, which assist in diagnosing and treating coronary arterial disease, peripheral vascular disease, and other nonvascular diseases, and includes embolotherapeutic, cardiac rhythm management CRM , electrophysiology EP , and interventional oncology and spine devices.

Its endoscopy segment consists of gastroenterology and pulmonology medical devices, which assist in the palliative treatment of expanding esophageal, tracheobronchial, and biliary strictures caused by malignant tumors.

Prestige Brands Holdings Inc. Ypsomed Holding AG is a Switzerland-based holding company engaged in the manufacture of injection pens for pharmaceutical and biotech companies. The company develops and manufactures injection systems for custom-made self-administration, and it markets pen needles for the treatment of diabetes, growth disorders, or infertility. The company operates two business segments: Injection Systems and Diabetes Care. In the Injection Systems segment, the company's Ypsomed Delivery Systems YDS offer a range of ready-to-use injection systems for pharmaceutical and biotech companies to administer drugs or to develop and manufacture them in line with customer requirements.

The Diabetes Care segment markets products such as pen needles or insulin pumps to diabetes patients and to doctors and health insurance providers. The company operates its production sites in Burgdorf, Solothurn, Grenchen and Tabor and has sales and distribution network across Europe. Glaukos Corporation, incorporated on July 14, , is an ophthalmic medical technology company.

The company focuses on the development and commercialization of products and procedures for the treatment of glaucoma.

It has developed the microinvasive glaucoma surgery MIGS to serve as an alternative to the traditional glaucoma treatment and management paradigm. The iStent is a micro-bypass stent inserted through a small corneal incision made during cataract surgery and placed into Schlemm's canal, a circular channel in the eye that collects aqueous humor and delivers it back into the bloodstream.

It is developing three additional pipeline products: the iStent Inject, the iStent Supra, and the iDose. The iStent Inject includes two stents preloaded in an autoinjection inserter. The iStent Supra is designed to access an alternative drainage space within the eye. AtriCure Inc. The company develops, manufactures, and sells devices designed primarily for the surgical ablation of cardiac tissue, as well as systems designed for the exclusion of the left atrial appendage.

The company offers various minimally invasive ablation devices and access tools to facilitate less invasive cardiac and thoracic surgery. The company operates in the ophthalmic surgical market segment. The company's principal products are intraocular lenses IOLs used in cataract surgery and implantable collamer lenses ICLs used in refractive surgery.

The company makes lenses used in corrective or refractive surgery across the world and makes lenses for use in surgery that treats cataracts. We say, "The kit allows for the tip of the line to be accurately placed prior to tunneling Registration is free and gives you unlimited access to all of the content and features of this website.

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