ISO 13485 Certified Manufacturer
PMU & Tattoo Needle Cartridges
Manufacturer & Global Solutions
Tattoo needle cartridges, PMU cartridges, needle-free injectors, syringes, and insulin pen injectors, all made in our ISO-certified cleanrooms. OEM/ODM service with CE, FDA, and KFDA compliance support for global brands.
Class 100,000 Cleanrooms
Global Clients
Years Experience
In-house EO Sterilizers
Precision Medical & Tattoo Consumables, Built for Professionals
From our flagship needle-free injection system to sterile tattoo cartridges and syringes — every product is manufactured in ISO 13485 certified cleanrooms.
Needle-Free Multi-Dose Pen Injector System
Painless, needle-free medication delivery for diabetes care and aesthetic treatments. The pen injector works as an integrated 3-part system — all three components are required for a complete injection.
Tattoo Needle Cartridges
RL, RS, Magnum, Bugpin, Membrane & more — sterile disposable cartridges for professional tattooing.
Pen Injector
60IU reusable insulin pen injector with 3ml cartridge and durable metal lid for daily diabetes management.
PMU Cartridges
Sterile disposable derma rollers and PMU needle cartridges for skin rejuvenation and permanent makeup.
Syringe
Sterile luer lock syringes, tri-bevel hypodermic needles and veterinary insulin syringes.
- ISO 13485 Certified
- CE Mark
- FDA Registered
- EO Gas Sterilized
- OEM / ODM Available
Manufacturing Excellence
Where Precision Meets
Medical-Grade Standards
Every cartridge is made in our ISO 13485:2016 certified facility, inside ISO Class 100,000 cleanrooms. From surgical-grade stainless steel needles to medical-grade plastic housings, every batch is traceable and consistent.
ISO Class 100,000 Cleanrooms
Pharmaceutical-grade environmental controls throughout production
304 Surgical Steel
Medical-grade Japanese-imported 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
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.
About R&G Bio
Trusted Tattoo Needle Manufacturer Since 2009
R&G Bio makes tattoo needles and PMU supplies, with a focus on high-quality needle cartridges. We have been at this since 2009 and work with distributors, private label brands, and professional artists in more than 50 countries.
We are a full-service cartridge tattoo needle manufacturer. We make the needle you need, put your brand on it, and provide the regulatory paperwork to go with it. Our ISO 13485:2016-certified facility keeps every product at medical-grade standards.
We control quality from raw material to final package: 304 surgical-grade stainless steel, medical-grade polymers, 100% EO gas sterilization, and batch-level traceability. Standard configurations or fully custom designs, we build needles that professionals trust.
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.