About R&G Bio
Your Direct Link to Medical-Grade Tattoo & PMU Manufacturing
Since 2009, we’ve been the trusted partner for international distributors, brands, and professional artists seeking reliable, high-quality tattoo needle cartridges and PMU supplies.
Who We Are
A Strategic Partner, Not Just a Supplier
R&G BIO is a leading tattoo needle manufacturer specializing in medical-grade tattoo and permanent makeup (PMU) products. Our 23,000 square meter production facility features Class 7 cleanrooms and fully automated assembly lines, guaranteeing the highest levels of cleanliness and process control.
We take pride in being a true turnkey partner—our in-house team handles everything from CE marking to technical dossiers for worldwide markets, including the FDA, KFDA, and Anvisa. Whether you need ready-to-ship disposable items or comprehensive OEM/ODM services, we ensure solutions meet your specific demands.
Our dedicated export staff ensures our partners can always communicate with us and receive shipments on schedule, anywhere in the world.
Premium Products
High-performance tattoo needles and PMU cartridges engineered for professional results.
Flexible OEM/ODM
Custom needle configurations, private labeling, and branded packaging with adaptable MOQs.
Global Compliance
Complete technical dossiers for CE, FDA, KFDA, Anvisa and other regional registrations.
Global Shipping
Dedicated export team ensuring on-time delivery to 50+ countries worldwide.
Our Mission & Vision
Dedicated to Excellence in Beauty Equipment Manufacturing
We strive to empower beauty professionals by offering exceptional, reliable products that enhance their artistry and ensure client safety.
We aim to provide the best solutions for beauty professionals everywhere, revolutionizing the beauty equipment industry through technology and expertise.
Our Mission
To provide the best tattoo needle and PMU cartridge solutions for beauty professionals everywhere, combining medical-grade precision with innovative manufacturing.
Our Vision
To revolutionize the beauty equipment industry through cutting-edge technology, medical-grade expertise, and unwavering commitment to safety and quality.
Precision
Every product manufactured to exact specifications with zero tolerance for defects.
Trust
Building lasting relationships through consistent quality and transparent communication.
Innovation
Continuously improving manufacturing processes and product designs.
Quality
Medical-grade standards in every aspect of production and service.
Manufacturing Excellence
Where Medical-Grade Standards Meet Aesthetic Precision
At R&G BioTech Medical, manufacturing isn’t just about making products — it’s about creating medical-grade solutions that practitioners trust and clients depend on. Our facility operates at the highest global standards.
ISO Class 7 Cleanroom
Pharmaceutical-grade contamination control with fewer than 10,000 particles per cubic foot of air.
Automated Production Lines
State-of-the-art automated systems ensure every device meets exact specifications with zero human error variance.
Medical-Grade Raw Materials
Quality starts at the source. We use only certified medical-grade 316L stainless steel with full traceability.
Quality Promise
Our quality control system ensures every product leaving our facility meets the strictest standards.
<0.02%
Defect Rate
50x better than industry standard
23,000m²
Production Facility
Class 7 cleanrooms + auto lines
100%
Batch Traceable
From raw material to delivery
Compliance & Quality Assurance
Meeting International Regulatory Standards
ISO
ISO 13485:2016
CE
CE Marked (MDR)
FDA
FDA Registered
KFDA
KFDA Approved
RoHS
RoHS Compliant
Our Manufacturing & Regulatory Credentials
R&G BIO is dedicated to the highest standards of medical-grade manufacturing.
Our factories, as integrated manufacturers, hold ISO certification, which serves as the foundation of our quality system.
Our rigorous standards guarantee that every tattoo needle and PMU tip provided by R&G BIO adheres to the highest global safety, precision, and compliance benchmarks.
|
Aspect |
CE (Europe) |
FDA (USA) |
|---|---|---|
|
Regulatory Body |
European Commission / Notified Bodies |
US Food & Drug Administration |
|
Classification |
Class I, IIa, IIb, III (Risk-based) |
Class I, II, III (Risk-based) |
|
Tattoo Needles |
Typically Class IIa |
Class I / II (510(k) may be required) |
|
Quality System |
ISO 13485 required |
21 CFR Part 820 (QSR) |
|
Technical Docs |
Technical File / Design Dossier |
510(k) Premarket Notification |
|
Post-Market |
Vigilance system, PSUR |
Medical Device Reporting (MDR) |
Why Choose R&G Bio
Our Unique Value Proposition
01
Unmatched Quality Control
Less than 0.02% defect rate — 50x better than industry standard. Every batch traceable to raw material source.
02
Global Compliance Support
Complete CE, FDA, KFDA, Anvisa documentation. In-house regulatory team handles everything.
03
Custom OEM/ODM Solutions
Tailored needle configurations, private labeling, branded packaging with flexible MOQs.
04
Advanced Technology
Fully automated production lines with computer-controlled precision and real-time monitoring.
05
Strategic Partnerships
Long-term relationships with ISO 9001 certified suppliers and medical device equipment manufacturers.
06
Robust Supply Chain
Dedicated export team, on-time delivery to 50+ countries, complete logistics support.
CUSTOM BRANDING AVAILABLE
Contact us for wholesale pricing and custom configurations
Get In Touch
Request a
Quotation
Tell us about your requirements and our team will respond within 24 hours with a detailed quote including pricing, lead times, and customization options.