Manufacturer with FDA Registration for IVD | Hochuen

Hochuen Medical has passed FDA registration and obtained ISO certifications. The company is one of the largest OEM/ODM manufacturers in IVD in China.

Importance Of FDA Registration For A Medical Device Manufacturer

Are you planning to choose a medical device manufacturer to supply quality medical goods? Then, you should choose a manufacturer with FDA registration.

Are you a surgeon? You know the importance of using the proper medical devices on your patients. Only then, you keep yourself away from medical malpractice cases. So, on the verge of finding the right medical device manufacturer, you can do one thing. Yes, you can look for a manufacturer producing medical devices and medicines with FDA registration.

What Is FDA Registration?

FDA registration can do a lot for medical device manufacturers. This registration will ensure that the FDA or Food and Drug Administration is aware of the manufacturer and the devices he produces.

What Is The Role Played By FDA?

FDA is a government agency in the US. This agency is responsible for safeguarding the public, particularly their health. This authority regulates a wide range of consumer products. Examples include tobacco, veterinary products, cosmetics, electronics that emit radiation, medical devices, vaccines, medications, and food. Even the authority regulates products under other categories.

FDA safeguards public health by ensuring the security, efficiency, and safety of these products. The authority makes sure that the products are safe to use. Also, it makes sure that the benefits are more than the potential risks. The authority also checks whether the products meet the intended purpose, as the manufacturer claims. Further, the body ensures that the products have not tampered intending to cause harm to the users. This is why OTC medicines come with foil seals.

FDA Classification Levels of Medical Devices:

Let us consider that a medical device manufacturer with FDA registration approaches the FDA to approve a product. The government agency will classify the product under one of the three different categories. The categories are classes I, II, and III. The authority will identify a product's category based on the potential risks associated with using the product. Medical devices here denote everything, including life-saving pacemakers to simple tongue depressors.

Why Choose a Medical Device Manufacturer With FDA Registration?

A medical device manufacturer with FDA registration will bring you the confidence of getting the proper medical products.

Not just for medications, the FDA needs the medical device manufacturers with FDA registration to establish that their products are safe to use before selling them. Also, the authority makes it essential for the manufacturers to prove one thing. Yes, they will have to demonstrate adherence to appropriate manufacturing practices and processes. At Hochuen, with FDA registration, we wish to reiterate that you can feel safe about using our products.

Who We Are?

At Hochuen Medical, we hold the pride of being one of the largest ODM/OEM manufacturers of wearable medical products, medical devices, medical disposables, and IVDs. As we have the FDA registration, we produce every device with the approval of this body. We also have the expertise in offering prototyping services at an affordable cost. Along with FDA registration, we are also OHSAS 18000m ISO 14001, ISO 9001, and ISO 13485-registered.


In short, a medical device manufacturer with FDA registration will bring you confidence in your profession. We know that our clients look to provide the best service to their clients. So, we are committed to bringing only the best products to our clients. In turn, they can serve their clients best and grow their profession or business. So, what are you waiting for? Choose us for your quality medical-device needs and be a torch-bearer in your profession. Quality is what we assure you with our FDA Registration.

About us / 公司简介
Welcome to Hochuen Medical
Hochuen Medical is one of the largest OEM/ODM manufacturers in IVD and medical disposables & devices and wearable medical products in China.  We are specialized in precision die-cutting, lamination, injection molding, microfluidic cartridges, blister packing, plastic bonding, CNC machining, laser machining, printing, soft goods manufacturing, wearable devices and electronic accessories manufacturing, device assembly, embedded electronics, device integration, and packaging.  We not only provide volume production to customers, but also provide prototyping service at low cost. Hochuen is FDA registered, ISO 13485, ISO 9001, ISO 14001, and OHSAS 18000 certified.
/ 产品展示 MORE>>
2014 - 07 - 01
Plastic fabrication
Offering precision machining and fabrication of various kinds of engineering grade plastic including but not limited to PC, PMMA, COC, PS, with width and depth from millimeter to micrometer.
2014 - 07 - 01
Plastic polishing
Polycarbonate (PC) can be polished to achieve improved transparency surface after machining, which is useful for application using optical testing for early stage of the component development.
2014 - 07 - 01
Plastic bonding
Hochuen offers flexible bonding methods such as ultrasonic bonding, laser welding and adhesive bonding for plastic components and silicon materials.
2014 - 07 - 01
Electrochemical biosensors
Sensors and electrodes are used for electrochemical detection and electric conduction can be provided.
2014 - 07 - 01
Hochuen offers the integration service for different component on a device and integration of electrode on microfluidic devices.
2017 - 08 - 21
Assembling of partial or all components into a complete package with high efficiency and low cost can be realized in Hochuen.
新闻动态 / News MORE>>
2021 - 04 - 27
点击次数: 20
May 13-16, 2021, the Spring Exhibition of China International Medical Device Fair (CMEF) will be held in Shanghai. Hochuen Medical sincerely invites you to attend 2021CMEF China International Medical ...
2021 - 03 - 16
点击次数: 23
The 18th China International Laboratory Medicine & Blood Transfusion Instruments & Rereagent Expo (CACLP) and the 1st China International IVD Upstream Raw Materials & Manufacturing Circula...
2021 - 02 - 28
点击次数: 39
The Bio-Trade Exhibition is the first exhibition to create the bio-industry field in China.Hochuen Medical will attend the 6th EBC Bio-Trade Conference on March 11-13, 2021. We are looking forward to ...
T: +1-626-241-0354  
Los Angeles CA, US
T: 86-755-28140812  
Building 2, Chungkin Ind. Estate, Huaxing Road, Dalang, Longhua District, Shenzhen, China.






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