Certifications
Medical devices aren't for everyone. Every certificate is a ticket to market.
ISO 13485
Medical Device QMS
Internationally recognized quality management system for medical devices, covering design to post-market.
ISO 9001
Quality Management System
ISO-certified quality management ensuring product consistency and customer satisfaction.
CE Marking
EU Market Access
Products meet EU health, safety, and environmental standards for free circulation in Europe.
FDA Registered
US Food & Drug Administration
FDA-registered facility. Products cleared for the US market.
Class I Medical Device
China NMPA Filing
Legally registered Class I medical device manufacturer in China. Valid indefinitely.
TÜV Rheinland Verified
Alibaba Gold Supplier
On-site audit by TÜV Rheinland covering 12 capability areas: production, QC, R&D, and more.
Guangdong High-Tech Product
Provincial Certification
Antibacterial and anti-mold rehabilitation chair certified as a Guangdong High-Tech Product 2026.
EU Design Patent
Intellectual Property
Product design registered and protected by the EU Intellectual Property Office.
