ISO 13485 Certified Manufacturer
PMU & Tattoo Needle Cartridges
Manufacturer & Global Solutions
Premium cartridge tattoo needles and PMU supplies manufactured in ISO-certified cleanrooms. OEM/ODM services with CE, FDA, and KFDA compliance support for global brands.
✅ 17+ Years Experience ✅ CE & FDA Registered ✅ Global Shipping
Manufacturing Facility
Global Clients
Years Experience
Sterile Production
Our Products
Cartridge Tattoo Needles
& PMU Supplies
Comprehensive range of professional tattoo needle cartridges designed for precision, safety, and consistent performance. Available in multiple configurations for liners, shaders, and magnum work.
Manufacturing Excellence
Where Precision Meets
Medical-Grade Standards
Every cartridge is produced in our ISO 13485:2016 certified facility within ISO Class 100,000 cleanrooms. From surgical-grade 316L stainless steel needles to medical-grade plastic housings, we maintain complete traceability and batch consistency.
ISO Class 100,000 Cleanrooms
Pharmaceutical-grade environmental controls throughout production
316L Surgical Steel
Medical-grade stainless steel with mirror finish polishing
Batch Traceability
Complete quality documentation and lot tracking for every production run
100% EO Gas Sterilization
ISO 11135 validated sterile packaging with sterility assurance
Our Process
End-to-End Manufacturing Control
Needle Configuration
Custom needle groupings, tapers, and diameters engineered to your specifications
Precision Assembly
Automated cartridge assembly with micron-level accuracy and consistency
Quality Control
100% visual inspection plus 30% random sampling under 100x microscopy
Sterile Packaging
Individual blister packs with EO gas sterilization and expiration dating
Certifications
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.
About R&G Bio
Trusted Tattoo Needle Manufacturer Since 2009
R&G Bio is a top maker of tattoo needles and PMU supplies, with a focus on high-quality cartridge tattoo needles. We have been in business for more than 15 years and work with tattoo supply distributors, private label brands, and professional artists in more than 50 countries.
We are a full-service cartridge tattoo needle supplier, which means we can make whatever kind of needle you need, put your brand on it, and provide all the necessary regulatory paperwork. Our ISO 13485:2016-certified facility makes sure that every product fulfills the highest medical-grade standards.
We are dedicated to quality from getting the raw materials to putting the final package together. We only use 316L surgical-grade stainless steel and medical-grade polymers. They are 100% EO gas sterilized and can be traced down to the batch level. R&G Bio makes tattoo needles that experts trust, whether you need conventional configurations or special customized designs.
17+
Years of Excellence
50+
Countries Served
OEM / ODM SERVICES
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.