About R&G Bio
Your Direct Link to Medical-Grade Tattoo & PMU Manufacturing
Since 2009, we have been the manufacturing partner for distributors, brands, and professional artists who need reliable, high-quality tattoo needle cartridges and PMU supplies.
Who We Are
A Strategic Partner, Not Just a Supplier
R&G Bio is a tattoo needle manufacturer focused on medical-grade tattoo and permanent makeup (PMU) products. Our 23,000 m² production facility has ISO Class 7 cleanrooms and fully automated assembly lines, built for strict cleanliness and process control.
We work as a true turnkey partner. Our in-house team handles everything from CE marking to technical dossiers for worldwide markets, including FDA, KFDA, and Anvisa. Whether you need ready-to-ship disposables or full OEM/ODM service, we build to your requirements.
Our export team stays in touch and on schedule, so your shipments arrive on time, 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.
Who’s Who
One Operation, Three Roles — The Names Behind R&G Bio
You may see more than one company name on our certificates, contracts and product documentation. Here is exactly how it works — there is no subcontracting and no middlemen involved.
R&G Bio (RGBIO)
The name our overseas customers deal with. RGBIO handles all international sales, export documentation, logistics and after-sales support — one dedicated export team serving distributors and brands in 50+ countries.
Jiangsu Zhiyu Medical Instrument Co., Ltd
The manufacturing entity. Our 23,000 m² production facility, the U.S. FDA establishment registration (No. 3009392898) and the ISO 9001 / ISO 13485 quality certifications are held under this name.
Taizhou Zhiyu Medical Cosmetology Co., Ltd
Holds the EU compliance documents for our tattoo needle cartridge range — the CE Verification of Conformity (ICR/VC/HM2502114) and the RoHS 2.0 test report — issued at the same facility.
Our Mission & Vision
What Drives Us
We make reliable, safe tools for tattoo and beauty professionals, so they can focus on their work and their clients.
Our goal is simple: better manufacturing, honest service, and products professionals can trust.
Our Mission
Give tattoo and beauty professionals the needle and cartridge solutions they need, built with medical-grade precision.
Our Vision
Raise the standard of beauty and tattoo equipment through technology, expertise, and an uncompromising approach 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 Bio, manufacturing is not just about making products. It is about making tools professionals can trust on their clients’ skin. Our facility runs to 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
Automated systems keep every device to exact specifications, with minimal variation between batches.
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 makes sure every product leaving the factory meets the strictest standards.
<0.02%
Defect Rate
defect rate in final inspection, per 2025 internal QC data
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
We hold ourselves to medical-grade manufacturing standards on every product we ship.
We are an integrated manufacturer with ISO certification, and that certification is the foundation of our whole quality system.
Our quality standards exist for one reason: every tattoo needle and PMU tip we ship has to meet strict global safety, precision, and compliance requirements.
|
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
What You Get Working With Us
01
Unmatched Quality Control
Less than 0.02% defect rate in final-inspection sampling, per 2025 internal QC records. Every batch traceable to raw material source.
02
Global Compliance Support
Complete CE, FDA, KFDA, and Anvisa documentation, handled by our in-house regulatory team.
03
Custom OEM/ODM Solutions
Custom needle configurations, private labeling, and 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
A dedicated export team, on-time delivery to 50+ countries, and full logistics support.
CUSTOM BRANDING AVAILABLE
Contact us for wholesale pricing and custom configurations
Get In Touch
Request a
Quotation
Tell us what you need and our team will reply within 24 hours with a detailed quote covering pricing, lead times, and customization options.