Free Sale Certificate issued by EU Authorized Representatives for non-EU medical device manufacturers seeking market access in the EU and UK. Certifies product compliance with European regulatory requirements and facilitates seamless registration with MHRA and EUDAMED systems.
Manufactured by
EUCEREP B.V.
Eindhoven, Netherlands
EUCEREP | Global Regulatory Representation Market Access EUCEREP serves as your trusted EU Authorized Representative, UK Responsible Person, and FDA Agent, ensuring full-spectrum regulatory compliance across Europe, the UK, and the United States. We act as the official liaison with competent authorities, managing technical documentation, product registration, and post-market surveillance with precision and speed. From MDR and IVDR to MHRA and FDA pathways, we empower global manufacturers to achieve seamless market access and sustained compliance. Our expertise spans diagnostics, health tech, and high-risk medical devicesdelivering strategic oversight and operational clarity. Headquarters: Eindhoven, Netherlands Strategic Office: United Kingdom (for UK representation) Global Reach: Supporting manufacturers across Europe, North America, and the Middle East with dedicated regulatory solutions.
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Maven Profcon Services LLP
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Maven Profcon Services LLP · India
Regulatory consulting service supporting medical device manufacturers in obtaining European Free Sale Certificates through EU MDR compliance and CE marking assistance, including technical documentation preparation and conformity assessment support.
MedNet EC-REP GmbH · Germany
Free Sales Certificate (FSC) documentation service for medical devices, IVDs, and regulated products entering European markets. Supports regulatory compliance and market access across EU, UK, and Switzerland under MDR, IVDR, and related frameworks. Essential for manufacturers requiring proof of legal status in non-EU origin countries.
CMC Medical Devices & Drugs S.L. · Spain
We offer Free Sale Certificate (FSC) services to support the export of your products and comply with international regulatory requirements.
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