EU Authorized Representative
We represent third-country manufacturers in the EU market: conformity review, EUDAMED registration, technical documentation and authority communication.
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Our mission: technical trading with know-how
Medical technology from Dresden — German precision, global manufacturing
IBP & ECG adapter cables, compatible connectors and OEM medical solutions. As a certified EU Authorized Representative we guide manufacturers safely into the European market — from idea to series delivery.
since 2016 in DresdenISO 13485CE / MDRTÜV Süd · RheinlandEC-REP EU Authorized Rep.
Trusted by manufacturers & hospitals
B. BraunCodanLevitronixEdwardsSANA HospitalsHelios
3.2M+
adapters sold
480+
km of assembled cable
9.5T+
active customers
3
languages · DE · EN · 中文
Services
Four competencies, one responsibility
From regulatory representation through trade to in-house manufacturing — Tri Rad covers the entire medical-technology value chain. Everything from a single source.
Distribution & Trade
Compatible IBP and ECG adapter cables and connectors for nearly all monitor platforms — verified signal quality, custom lengths, MDR-compliant.
Learn more →Mold Making
Custom injection-molding tools for precise, repeatable plastic components — from small batches to large-scale production, specialized in medical technology.
Learn more →Automatic Assembly Machines
From idea through design and production to worldwide commissioning: scalable, CE-certified automation solutions — Made in Germany.
Learn more →Products
Precision that connects
Our product classics stand for the highest signal quality and durability — developed to German standards, manufactured under strict quality control.
01
IBP Adapters & Cables
Invasive blood-pressure monitoring: highest precision, durable medical TPU, custom lengths.
02
ECG Adapter Cables & Connectors
Compatible connections for nearly all common monitor platforms.
03
OEM Medical Solutions
Tailored products for your specific requirements — from specification to series.
04
Pressure-sensor Accessories
Guidewires, pressure extension tubes and infusion sets — MDR-compliant.
EC-REP · European Authorized Representative
Your gateway to the European market
Manufacturers without an EU base require an authorized representative under Article 11 of the Medical Device Regulation (MDR 2017/745). Tri Rad takes on this role — based in Dresden with deep understanding of German-Chinese trade relations.
- Review of EU declaration of conformity & technical documentation
- EUDAMED registration & compliance with reporting duties
- Communication with authorities on preventive & corrective actions
- Keeping documentation available for competent authorities
Dresden · Europe · China
Two worlds, one quality promise
Tri Rad Medical GmbH was founded in Dresden in 2016 — against the backdrop of the growing German-Chinese strategic partnership. We combine a deep understanding of both economic and cultural spheres.
Our products are developed to strict German standards and manufactured in China under the highest quality control. The result: competitive solutions for Europe and the global market.
Corporate culture
Teamwork, quality, innovation
Teamwork & trust
Experience and technical know-how in an open, dynamic working environment.
Uncompromising quality
End-to-end control from development to delivery.
Innovation & excellence
Continuous improvement and the pursuit of the best solution.
Sustainability & responsibility
Ethical conduct and a positive contribution to customers, staff and society.
Quality & certificates
Highest standards for your safety
Tri Rad meets all relevant international medical-technology requirements — certified since 2016.
ISO 13485:2016 Quality management
CE / MDR European conformity
TÜV Süd Quality Management System
TÜV Rheinland EN ISO 13485:2016
Process
From idea to global delivery
Everything from a single source — for maximum quality and minimum friction.
1
Enquiry & analysis
We assess your requirement technically and economically — including feasibility.
2
Design & engineering
Design and specification, matched to your platform and volume.
3
Samples & approval
Prototypes, testing and validation before the series.
4
Manufacturing
Series production under strict quality control.
5
Delivery & support
Worldwide delivery, commissioning and reliable after-sales support.
News
Always up to date
ISO 13485 certification successfully passed
We hold all key certificates to support you with your challenges.
Our new web presence
New spirit, new look — a modern presence in three languages.
Tri Rad at Medica
Meet us in person and arrange an appointment.
FAQ
Answers for purchasing & development
Manufacturers of medical devices based outside the EU require a representative established in the Union under MDR Art. 11. This representative assumes regulatory duties such as EUDAMED registration and authority communication. Tri Rad takes on this role for you.
Yes. Our products are continuously adapted to current EU requirements and extensively tested. They are ISO 13485 certified and CE-marked.
Yes. We assemble custom cables in individual lengths and configurations and develop tailored OEM medical solutions — from specification to series.
With nearly all common platforms, including Mindray, Philips, GE, Dräger, B. Braun, Edwards, Utah, Smiths, Datascope, Spacelabs and Argon — across more than nine connector types.
Development to German standards in Dresden, manufacturing in China under strict quality control. This combines precision with competitive, global manufacturing.
Your project, our expertise
Whether series demand, OEM development or EU market access — talk to us.
Contact
Let's talk
We look forward to your enquiry — in German, English or Chinese.
AddressTiergartenstraße 32
01219 Dresden
01219 Dresden
Phone+49 351 000000
Emailinfo@trirad.de