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.
Professional Thermage FLX Radio Frequency Skin Tightening Machine | Non-Surgical Face & Body Lifting
The Thermage FLX Radio Frequency Skin Tightening Machine is a next-generation non-invasive lifting system designed for professional anti-aging, wrinkle reduction, and body contouring. Using advanced monopolar RF technology, the Thermage FLX delivers uniform heating deep into the dermis to stimulate collagen regeneration, tighten loose tissue, and redefine facial and body contours without surgery or downtime.
Equipped with intelligent temperature monitoring, fast pulse technology, and ergonomic treatment tips, the Thermage Flx system ensures safe, comfortable, and visible lifting results. This device is ideal for beauty clinics and professional aesthetic centers seeking a premium RF tightening solution comparable to high-end Thermage systems.
HI-8D HIFU Machine – Professional Multi-Line High-Intensity Focused Ultrasound System
The HI-8D HIFU machine is an advanced high-intensity focused ultrasound device designed for professional face and body lifting treatments. Using innovative multi-line ultrasound technology, this Hifu machine delivers precise focused energy deep into the SMAS layer, triggering collagen regeneration and thermal coagulation for noticeable lifting and firming effects.
Compared to traditional HIFU systems, the HI-8D supports single-line + multi-line + multi-frequency + 360° line-sculpting, enabling faster treatment speed, higher accuracy, and enhanced client comfort.
This professional-grade Hifu machine is ideal for non-invasive wrinkle removal, jawline lifting, skin tightening, body contouring, and overall rejuvenation, making it a powerful solution for beauty salons and aesthetic clinics seeking reliable lifting technology.
3-in-1 HIFU Machine price 7D HIFU + Vaginal HIFU + Gold RF Micro-Needling System
The 3-in-1 HIFU Machine combines 7D HIFU, vaginal rejuvenation HIFU, and Gold RF micro-needling into a single advanced system, delivering comprehensive anti-aging and skin regeneration solutions.
The 7D HIFU machine targets multiple facial and body layers using precise ultrasound energy to tighten skin, reduce wrinkles, and contour the face & body without downtime.
The vaginal HIFU system provides effective intimate tightening, collagen regeneration, and moisture improvement.
The Gold RF Micro-Needling module improves skin texture, reduces acne scars, and promotes collagen remodeling for long-lasting rejuvenation.
Ideal for professional beauty clinics and aesthetic centers, this machine offers the perfect combination of lifting, tightening, rejuvenation, and intimate wellness treatments.
7D HIFU Skin Lifting Machine – Professional Non-Invasive Face & Body Tightening System
The 7D HIFU Skin Lifting Machine is an advanced non-invasive ultrasound system designed for professional face and body tightening. By delivering high-intensity focused ultrasound energy into multiple skin layers—including the SMAS, dermis, and subcutaneous tissue—the device achieves instant lifting, long-lasting tightening, and natural rejuvenation.
Compared to traditional RF or micro needle machine treatments, 7D HIFU reaches deeper structural layers, creating a natural lifting effect without surgery or downtime. It is widely used in beauty salons, medical spas, and aesthetic clinics for wrinkle reduction, jawline contouring, skin firming, and non-invasive body sculpting.
With multiple cartridge depths and precision ultrasound technology, this device ensures accurate, safe, and highly effective treatments for both face and body. It is one of the most popular non-surgical anti-aging devices for professional aesthetic businesses.
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