About AFINA s.r.o.

getEAR.eu is a service of AFINA s.r.o. We support non‑EU manufacturers with EU representation and regulatory compliance services — with a strong focus on medical devices (MDR) and IVD (IVDR).

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Why our company can be useful to you

Founded in 1996

The experience we have helps you avoid common mistakes when entering the EU market. Over the years we have solved many complex cases and can support you even in difficult situations thanks to accumulated experience.

We are professionals

Our competencies and knowledge of EU/Czech requirements help you choose a clear and practical strategy for EU market access.

Contact information

AFINA s.r.o.

Praha — StarĂ© MÄ›sto
Kaprova 42/14
110 00 Prague
Czech Republic

Company ID (IÄŚO): 25056557
Email: [email protected]
Phone: +420 608 049 029

Credentials

Registered in EUDAMED as an Economic Operator (EO) — European Authorised Representative (EAR): View our EUDAMED entry
PRRC support for medical device manufacturers (scope confirmed case‑by‑case)
EU representation and onboarding workflows built for real operations (not only documentation)

Official representation & partners

We collaborate with established certification bodies and institutions. Below are selected examples with links to official sources.

ITC ZlĂn (CZ) — official trade representation by AFINA s.r.o. for selected territories.

Website Source

SZĂš Test (CZ) — SZU Eastern Europe sales office represented by AFINA s.r.o.

Website Source

CMI (CZ) — cooperation.

Website

TZĂšS (CZ) — cooperation.

Website

3EC (SK) — cooperation.

Website

Xportkat (PL) — Krakow-based consultancy, clinical evaluation & digital health compliance.

Website Contacts

Names and logos are used for identification and reference; official details are available via the linked sources/websites.