GATE-U Limited is a Hong Kong-based regulatory consultancy helping medical device and IVD manufacturers from Hong Kong, Shenzhen, and the Greater Bay Area access the European Union market.
We are the local sister company of MDRC s.r.o. (Slovakia), a European consultancy with 10+ years of experience and over 100 successful CE-marking projects across EU MDR and IVDR.
Our services include:
- EU Authorized Representative (EC-REP) services
- CE-marking strategy and Notified Body coordination
- Development of MDR/IVDR-compliant technical documentation
- EU AI Act compliance support
- ISO 13485 implementation support and post-market compliance
- Regulatory training for client teams
- Local EU entity setup
Based in Hong Kong but backed by a European regulatory team. Our mission is to make EU market entry fast, smooth, and cost-effective for Asia’s MedTech innovators.
www.gateu.hk
info@gateu.hk
Company Details
- Employees
- 5
- Founded
- -
- Address
- Hong Kong Sheung Wan Unit 1603, 16th Floor, The L. Plaza 367 - 375 Queen's Road Central, Hong Kong Sar,hong Kong
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- http://gateu.hk/
- HQ
- Hong Kong SAR
Gate-U Questions
Gate-U's website is http://gateu.hk/
Gate-U's LinkedIn profile is https://hk.linkedin.com/company/gate-u
Gate-U has
5 employees.
View email and phone details for 5
employees at Gate-U.
Gate-U's industry is
Business Consulting and Services
Gate-U's top competitors are
Inspektion Solutions,
Seafoodfriday.hk,
Mdrc S.r.o.,
Bg18 International Limited,
Dora.group Gmbh,
Fimabo S.r.o.,
Robotdreams® Gmbh,
Hong Kong Medtech Association,
Nexareg,
Dispo Line Relay.
Gate-U's categories are Business Consulting and Services
Gate-U's founding year is 2025
