FDA Cleared
Class II Medical Device, 510(k)
cGMP Manufacturing
Stringent cGMP protocols
PRP · PRF · Exosomes
Microneedling and Centrifuges
Training and Support
For representatives and distributors
Manufacturer of FDA-cleared Platelet-Rich Plasma (PRP) Kits
Currently, we are starting this service offering with:
Each product we distribute is best-in-class for performance, value, customer service, and profitability.
PRP & PRF Centrifuges
NanoPen® Microneedle Devices
Exosomes & Allografts
Shockwave Systems
- Product classification
- Custom product packaging
- Design
- 15mL
- 22mL
- 30mL
- Standard-density
- High-density gel
“We seek long-term strategic allies with a medical professional following to work with as we expand our Regenerative Medicine network.”
MedGeneRx® HP 30 PRP Kit
Class II Medical Device · 510(k)
MedGeneRx® HP 30 PRP Kit is FDA Cleared and indicated for the rapid preparation of autologous Platelet Rich Plasma (PRP) from a small sample of blood at the patient’s point-of-care.
- 30cc Protocol
- FDA Cleared, Class II Medical Device, 510(k)
- Integrated anticoagulant – No ACD-A needed
- Vacutainer system for simplified blood collection
- Compatible with existing 30mm diameter centrifuges
SKU
ZG-PRP-HP30
MedGeneRx® HP 30 PRP Kit Components
(1) MedGeneRx® HP 30 Vacutainer
Optional Accessories
(2) 10cc Syringes
(1) 21g Butterfly Needle
(1) 3 inch 19g Spinal Needle
510(k) equivalence study conducted and the following mean results were achieved:
| Platelet Concentration Factor at 0 hours | 3.8-4.1x baseline |
| Platelet Concentration Factor at 1 Hour | 4.1-4.3x baseline |
| Platelet Recovery % at 1 hours | 53% |
| RBC at 0 hours / 4 hours | 0.1 / 0.01 |
| pH at 0 hours / 4 Hours | 7.59 / 7.69 |
| Platelet Aggregation at 0 / 4 Hours | 95.1% / 94.8% |
| WBC at 0 / 4 hours | 0.3 / 0.3 |
Centrifuges
ZG-TD4B-01 customized laboratory centrifuge machine is compact, versatile, and produces consistent and exceptional results.
PRF Tubes
Indicated for the rapid preparation of autologous Platelet Rich Fibrin (PRF) from a small sample of blood at the patient’s point of care.
Topical Serums
Our low molecular weight 100% Hyaluronic Acid Dual Molecule is formulated with the purest form of water-soluble hyaluronic acid.
RegenOMedix™ ZG-TD4B-01
10 INTEGRATED PROGRAMS
MAXIMUM SPEED
Orthopedic, Aesthetic, Hair Restoration,
Wound Healing and Sexual Wellness
Orthopedics
Gained traction in both orthopedic and chiropractic practices.
Aesthetics
Gained popularity in the field of aesthetic medicine.
Hair Restoration
Recognition as a promising treatment option for hair restoration.
Wound Healing
For its potential therapeutic applications in wound healing.
Sexual Wellness
Potential treatment option in the field of sexual wellness.
Give your medical clients what they need for increased success.
Our PRP Kits have successfully met the rigorous standards set by the FDA, underscoring our unwavering commitment to providing products of exceptional quality and safety. By aligning with us, sales representatives and distributors can confidently offer healthcare professionals a trusted and reliable solution that meets the highest industry standards.
Backed by robust clinical evidence, our PRP Kits have demonstrated remarkable efficacy in various medical fields, including orthopedics, sexual wellness, dermatology, and aesthetic medicine. With our products, sales representatives and distributors can provide healthcare professionals with a proven and effective tool to significantly enhance patient outcomes and satisfaction.
By associating with our established brand, sales representatives and distributors can leverage our strong market acceptance and credibility. Our FDA clearance and track record of success position us as a trusted partner, enabling our collaborators to tap into a vast network of healthcare professionals who prioritize products with a solid reputation and proven results.
We prioritize the success and growth of our sales representatives and distributors. Therefore, we offer extensive training and support to ensure our partners have the knowledge and resources to promote and distribute our PRP Kits effectively. Our team of experts provides ongoing assistance, guidance, and marketing materials to facilitate successful product adoption and sales.
By joining forces with us, sales representatives and distributors can gain a competitive edge in the market. Our innovative PRP Kits open up lucrative opportunities for our partners to establish themselves as key players in the dynamic and rapidly expanding field of regenerative medicine. With our products, collaborators can effectively differentiate themselves and achieve remarkable success in their sales endeavors.
Distribution, Private Labeling, Regulatory & Manufacturing
Unlocking Success: The Lucrative Benefits of Becoming a Distributor of Our PRP Products
Unparalleled Quality
Our PRP products are meticulously crafted using state-of-the-art technology and adhere to industry standards.
Market Demand and Growth Potential
The global demand for PRP products is on an upward trajectory, driven by the growing preference for non-invasive, non-drug-oriented, regenerative treatments.
Comprehensive Support and Training
We prioritize the success of our distributors and understand the importance of continuous education and development.
Global Reach and Network Expansion
Joining our distribution network opens the door to a vast network of industry professionals and key opinion leaders in regenerative medicine.
Profitability and Sustainability
The financial rewards of becoming a distributor of our PRP products are substantial and sustainable.
Navigating Regulatory Success: Empowering Private Labeling of PRP Kits with Our Comprehensive Assistance
Expert Guidance Through Product Design and Compliance
Our experienced team is well-versed in the intricate nuances of the regulatory burdens and manufacturing requirements governing PRP products.
Customized Solutions for Your Unique Needs
Recognizing the diverse needs of our partners in the private labeling arena, we offer tailored solutions to align with your specific business objectives.
Quality Assurance and Compliance
We work closely with you while ensuring quality assurance and compliance are integrated into your products.
Streamlined Access to National Markets
As the global demand for PRP products continues to surge, gaining access to national markets is essential for expanding your private label’s reach and maximizing your business potential.
Strategic Partnerships for Long-Term Success
The heart of our private labeling assistance is a commitment to fostering enduring partnerships built on trust, transparency, and shared success.
Navigating Regulatory Success: Empowering the Distribution of Regenerative Medical products with Our Comprehensive Assistance
Expert Guidance Through Regulatory Compliance
Our experienced regulatory team is well-versed in the intricate nuances of the regulatory framework governing medical products.
Customized Regulatory Solutions for Your Unique Needs
Recognizing the diverse needs of our partners in the private labeling arena, we offer tailored regulatory solutions that align with your specific business objectives.
Quality Assurance and Compliance at the Forefront
Upholding the highest quality assurance and compliance standards is central to facilitating your private labeling requirements.
Streamlined Access to Global Markets
As the global demand for regenerative medicine products continues to surge, gaining access to international markets is essential for expanding your private label’s reach.
Strategic Partnerships for Long-Term Success
Our commitment to fostering enduring partnerships is built on trust, transparency, and shared success.
Elevating Standards: Ensuring Safety and Efficacy in Our PRP Kit Manufacturing Process
Uncompromising Commitment to Safety
Our manufacturing process adheres to stringent cGMP protocols, ensuring that every PRP kit is produced in compliance with current regulatory standards.
Advanced Technology and Innovation
Equipped with cutting-edge technology and dedication to innovation, our manufacturing facilities integrate the latest advancements in biomedical engineering to produce PRP kits at the industry’s forefront.
Stringent Quality Control Measures
Quality control lies at the core of our manufacturing process, serving as the cornerstone of our commitment to delivering superior products.
Collaborative Expertise and Industry Best Practices
Our manufacturing process is managed by a team of seasoned professionals who understand the intricacies of PRP therapy and regenerative medicine.
What does "FDA Cleared" mean?
FDA Cleared
FDA approval
However, it’s important to note that FDA clearance is not the same as FDA approval. The FDA clearance process typically involves a demonstration by the manufacturer that the device is substantially equivalent to a legally marketed device, known as a predicate device, that is already on the market.
What are the benefits of our PRP Kits being FDA Cleared?
Compliance and credibility
Market acceptance
FDA clearance often serves as a seal of approval, which can significantly enhance market acceptance.
Enhanced patient safety
Expanded use in clinical settings
Competitive advantage
Reimbursement opportunities
Many insurance companies and healthcare programs often require FDA clearance as a prerequisite for coverage.
What are the three phases of healing when PRP is injected?
Inflammatory phase
Helps to initiate the body’s natural healing process, attracting immune cells to the site of injury.
Proliferative phase
New collagen and other extracellular matrix components, helping to strengthen and repair the damaged tissues.
Remodeling phase
Achieve optimal tissue strength and function, ultimately restoring the injured area to its pre-injury state.
The Medical Use of Platelet Rich Plasma
Frequently Asked Questions
If a product is “FDA Cleared,” it means that the U.S. Food and Drug Administration (FDA) has reviewed and authorized the marketing of the product. However, it’s important to note that FDA clearance is not the same as FDA approval, which is a more rigorous process reserved for products that are deemed to be of higher risk, such as new drugs.
Platelet-Rich Plasma (PRP) is a concentrated solution derived from a person’s own blood that contains a high concentration of platelets. Platelets are small, disc-shaped cell fragments in the blood that play a crucial role in the body’s natural healing process. The process of obtaining PRP involves the following steps: 1. Blood Collection: A small amount of blood is drawn from the patient, typically from the arm. 2. Centrifugation: The collected blood is then placed in a centrifuge, a machine that spins at high speeds to separate the different components of the blood.
Performing Platelet-Rich Plasma (PRP) injections in a doctor’s office typically requires specific equipment to ensure the procedure is carried out safely and effectively. The following is a general list of equipment that might be needed: 1. Centrifuge: A high-quality centrifuge is essential for separating the platelet-rich plasma from the patient’s blood. A refrigerated centrifuge might be preferred to maintain the integrity of the platelets. 2. PRP Kit: This includes specialized tubes, syringes, and other materials necessary for drawing blood, processing it, and obtaining the platelet-rich plasma.
The specific licensing requirements for staff members to perform platelet-rich plasma (PRP) injections may vary depending on the state or country in which the practice is located. Medical License: In most jurisdictions, only licensed medical professionals, such as physicians, nurse practitioners, or physician assistants, are permitted to perform PRP injections.
Platelet-Rich Plasma (PRP) therapy has gained recognition as a potential treatment for hair restoration. Androgenetic alopecia (male-pattern baldness and female-pattern hair loss): PRP can be used to stimulate hair follicles, prolong the growth phase of the hair cycle, and improve the density and thickness of hair in individuals experiencing androgenetic alopecia. Alopecia areata: PRP may be utilized as a supportive treatment for alopecia areata, an autoimmune condition that causes patchy hair loss.
Platelet-Rich Plasma (PRP) has gained popularity in the field of aesthetic medicine for its potential benefits in skin rejuvenation. Wrinkle reduction: PRP can be used to stimulate collagen production, which can help improve skin elasticity and reduce the appearance of fine lines and wrinkles, particularly in areas such as the face, neck, and hands. Skin tone and texture improvement: PRP can help enhance skin tone and texture, leading to smoother, more even-toned, and radiant skin.