FirsTeckBio

An Italian IVD distribution and regulatory partner.

FirsTeckBio is a focused Italian team. We distribute selected in-vitro diagnostic products to Italian laboratories and clinics, and support IVD manufacturers entering the EU market with regulatory and clinical services.

Our reach & impact

Founded in 2021 by a team with IVD and regulatory backgrounds — the project experience behind our work.

  • 20+ IVDR projects: IVDR-related performance evaluation and regulatory projects completed or in progress.
  • 100+ diagnostic markers: Diagnostic markers evaluated across infectious disease, cardiac, women's health, POCT and more.
  • 50+ clinical departments: Partnered clinical and laboratory departments across Italy and the EU.
  • 70+ IVD companies: Collaborating IVD manufacturers and partners.

Company Profile

A focused, technically-oriented Italian company connecting international IVD products with Italian healthcare buyers.

  • Headquarters: Modena, Italy.
  • Core business: Italian IVD distribution and IVDR regulatory services.
  • Approach: Direct contact and expert answers — the team that picks up your call also runs your performance study and writes your technical documentation.

What We Do

Two complementary activities — product distribution in Italy, and regulatory support for manufacturers.

  • IVD distribution: Selected immunoassay, POCT, blood gas and rapid-test product lines for Italian buyers.
  • Regulatory services: IVDR documentation, EU Authorized Representative and PRRC services for manufacturers.
  • Clinical support: Performance evaluation and method comparison support in Italian laboratories.

Where We Work

Our active market is Italy, with a focus on public hospital laboratories, private clinical laboratories and outpatient clinics.

  • Italian laboratories: Direct relationships with hospital and private laboratories across Italy.
  • Market focus: Public hospital laboratories, private clinical laboratories and outpatient clinics.
  • Italian base: Our office in Modena handles sales, service and logistics.

Research & Cooperation

Academic collaboration that keeps our clinical expertise current.

  • University of Perugia: Cooperation with the Department of Medicine and Surgery, including performance-evaluation studies.
  • Microbiology scholarship: An annually funded scholarship supporting microbiology research at the University of Perugia.
  • Clinical network: Working relationships with clinical and laboratory departments across Italy — see Our reach & impact for the project numbers behind that network.

Connect with FirsTeckBio

Contact us for product, service, distribution or market access discussions.

Contact Us