HUIMAIN HIFU CE & FDA Registration Service
Professional HIFU CE & FDA Registration Service by HUIMAIN
HUIMAIN offers a clear, reliable HIFU CE and FDA registration service tailored for beauty and medical device manufacturers. Backed by a strong R&D team, experienced engineers, and a clinical test department, we help clients prepare complete technical files, arrange testing, and navigate regulatory processes with confidence.
What We Offer
Regulatory Assessment
We start with a full review of your HIFU device to determine the correct classification and the path for CE marking (MDR/IVDR where applicable) or FDA clearance/510(k). This step reduces surprises and sets a realistic timeline.
Documentation & Technical File
Our team prepares or reviews the technical file, risk analysis (ISO 14971), clinical evaluation reports, labeling, and instructions for use. We ensure documents meet EU and US requirements for submission.
Testing & Clinical Support
HUIMAIN coordinates required safety and performance testing (electrical safety, EMC, performance verification) and supports clinical data collection when needed. We work with accredited labs and our internal clinical test experts to ensure quality results.
Quality System Guidance
We advise on ISO 13485 implementation and documentation needed for regulatory review. A solid QMS shortens review time and supports long-term market success.
Why Choose HUIMAIN
With a 3,000 m² facility, strong technical staff, CE and SGS approvals, and multiple patents, HUIMAIN combines product knowledge with regulatory expertise. We specialize in OEM/ODM for beauty machines and have global market experience in Asia, the Middle East, Europe, and North America.
Simple, Transparent Process
Our service is step-by-step and client-focused: assessment, documentation, testing coordination, submission support, and post-market advice. We communicate clearly, set realistic timelines, and provide regular updates. While we guide and prepare the strongest possible application, final approvals rest with regulatory authorities.
Contact HUIMAIN today to streamline your HIFU CE and FDA registration process and bring your device to market with confidence.
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Question you may concern
What is an EMS Body Sculpting Machine?
An EMS Body Sculpting Machine is a non-invasive device that uses High-Intensity Electromagnetic (HIEMT) or Electrical Muscle Stimulation (EMS) technology to stimulate muscle contractions and promote fat reduction. It helps tighten, tone, and strengthen muscles in targeted areas such as the abdomen, buttocks, thighs, and arms.
Is this device suitable for everyone?
The device is suitable for most people but is not recommended for pregnant women or individuals with heart conditions. Please consult a professional before use.
How long does a treatment session take?
Treatment sessions typically last 30-60 minutes depending on the area being treated.
What body areas can be treated?
It can be applied to the abdomen, thighs, arms, buttocks, and legs for fat reduction and muscle toning.
If you have any questions about our goods or services, please feel free to contact us.
7D HIFU Machine | HF + VMAX Anti-Aging & Face Lifting System for Professional Use
The 7D 2-in-1 Ultrasound Machine is a cutting-edge aesthetic device designed for B2B professionals seeking a powerful and precise solution for anti-aging and face lifting. This floor-standing system combines two advanced technologies, HF and VMAX, to deliver accurate and effective results.
It uses upgraded focused ultrasound technology to target the dermis, superficial fascia, and SMAS fascia, covering all layers for comprehensive skin rejuvenation. With its single-point sliding treatment head, the machine offers a comfortable experience with a short recovery period, making it an ideal investment for clinics and medspas specializing in non-invasive skin tightening and wrinkle removal.
High Intensity Focused Ultrasound (HIFU) Facial Machine for Non-Surgical Skin Lifting and Tightening
This High Intensity Focused Ultrasound (HIFU) Facial Machine is designed for non-invasive skin tightening, wrinkle reduction, and overall facial rejuvenation. By targeting deep skin layers with focused ultrasound energy, it stimulates collagen production and enhances skin elasticity. Suitable for use on the face, neck, and jawline, this HIFU machine offers effective, long-lasting results without the need for surgery. With adjustable settings, it caters to various skin types and treatment preferences, ensuring a customized experience for each client.
4D HIFU Facial Machine – High Intensity Focused Ultrasound Technology for Skin Rejuvenation and Tightening
The 4D HIFU Facial Machine uses High Intensity Focused Ultrasound (HIFU) technology to deliver non-invasive skin rejuvenation and tightening treatments. This advanced facial machine targets deep layers of the skin to stimulate collagen production, reduce wrinkles, and provide lifting effects on the face, neck, and jawline. With adjustable energy settings and a user-friendly touchscreen interface, this device ensures precise treatment for every skin type. Ideal for beauty clinics and professionals, the 4D HIFU machine offers a safe and effective solution for clients seeking non-surgical cosmetic enhancements.
12D TT High Intensity Focused Ultrasound (HIFU) Facial Machine – Professional Skin Lifting & Tightening System
The 12D TT High Intensity Focused Ultrasound (HIFU) Facial Machine is a next-generation non-invasive skin rejuvenation system designed to lift, tighten, and contour the face and body. Using High Intensity Focused Ultrasound (HIFU) technology, this professional-grade device delivers focused energy deep into the dermal layers to stimulate collagen regeneration and improve skin elasticity.
Ideal for professional clinics and beauty centers, the 12D TT HIFU Facial Machine provides multiple depth treatments for precise and long-lasting results — with no downtime and no surgery required.
Let's Talk
Stay in touch with us for cutting-edge beauty solutions, professional guidance, and customized service.
Contact
Room 307, Building A, Huilong International E-commerce Industrial Park, No. 10 Xipengling Road, Helong Street, Baiyun District, Guangzhou, China
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