Compliance & Certificates
Every certificate below is issued by an independent body that you can verify yourself. Click any certificate to see the full document, or use the verification link to check it directly with the issuer.
International SalesR&G Bio (RGBIO) — our export and customer-service arm. All overseas inquiries, contracts, invoicing and after-sales support are handled by RGBIO.
Manufacturing · FDA · ISOJiangsu Zhiyu Medical Instrument Co., Ltd — the manufacturing entity. The factory, the U.S. FDA establishment registration (No. 3009392898) and the ISO 9001 / ISO 13485 certifications are held under this name.
EU Compliance · CE / RoHSTaizhou Zhiyu Medical Cosmetology Co., Ltd — holds the EU compliance documents (CE Verification of Conformity and the RoHS test report) for our tattoo needle cartridge range.
One operation, one facility. RGBIO, Jiangsu Zhiyu and Taizhou Zhiyu are affiliated companies under the same ownership and management, operating at the same address: No.88, Nanyuan Road, Industrial Park, Taixing, Jiangsu, China. Different certificates simply carry the name of the legal entity that holds them — production, quality management and regulatory compliance are run as a single integrated team, so overseas customers deal with one team from inquiry to delivery: factory-direct quality and pricing, with export-grade service.
U.S. FDA Registration Verification
Live data retrieved from the official U.S. FDA openFDA database (Registration & Listing)
Verifying with FDA database…
U.S. FDA Registration
FDA 510(k) Premarket Clearance
CE — Verification of Conformity (RoHS)
RoHS 2.0 Test Report
ISO 13485:2016 — Medical Devices QMS
ISO 9001:2015 — Quality Management
NMPA Device Registration — Derma Roller
EU MDR Certificate — TÜV Rheinland
At R&G Bio, compliance is not a once-a-year paperwork exercise. It is how we run the factory every day. Not sure which certificates your market needs? See our Certification Support guide →
CE vs FDA: Regulatory Comparison
Two systems, two sets of rules. Here is the short version.
|
Regulatory Body |
European Commission / Notified Bodies |
US Food & Drug Administration |
|---|---|---|
|
Classification System |
Class I, IIa, IIb, III (Risk-based) |
Class I, II, III (Risk-based) |
|
Microblading Needles |
Typically Class IIa |
Class I / II (510(k) may be required) |
|
Quality System |
ISO 13485 required |
21 CFR Part 820 (QSR) |
|
Technical Documentation |
Technical File / Design Dossier |
510(k) Premarket Notification |
|
Post-Market Surveillance |
Vigilance system, PSUR |
Medical Device Reporting (MDR) |