Finder EU notified body intelligence
2854

bqs. s.r.o.

🇸🇰 Slovakia · Trenčín, 911 01 Active

www.bqsgroup.eu

Designations

IVDR In vitro diagnostic medical devices · Regulation (EU) 2017/746 Active
Conformity assessment annexesAnnex III, Annex IV
Designated since2020-02-11
IVD 0100 IVD 0101 IVD 0102 IVD 0103 IVD 0200 IVD 0201 IVD 0202 IVD 0203 IVD 0300 IVD 0303 IVD 0305 IVD 0307 IVD 0309 IVD 0400 IVD 0401 IVD 0402 IVD 0403 IVD 0404 IVD 0405 IVD 0406
Full scope text from the register
Annexes
  • Annex III, Annex IV
Procedures
  • EC declaration of conformity (full quality assurance system), EC declaration of conformity
Products
  • *IVD 0401 - Clinical chemistry
  • *IVD 0309 - Device for self-diagnosis: device for the measurement of blood sugar
  • *IVD 0300 - Reagents, reagent products and devices for self-diagnosis, including related calibrators and control materials, for determining, detection, quantification, diagnosing, evaluating
  • *IVD 0402 - Haematology
  • *IVD 0305 - Human infections: cytomegalovirus, chlamydia
  • *IVD 0400 - Devices for self-testing
  • *IVD 0202 - HTLV I and II
  • *IVD 0200 - Reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of
  • *IVD 0404 - Molecular biology
  • *IVD 0201 - HIV infection (HIV 1 and 2)
  • *IVD 0203 - Hepatitis B, C and D
  • *IVD 0406 - Specimen receptacles
  • *IVD 0403 - Immunology
  • *IVD 0303 - Congenital infections: rubella, toxoplasmosis
  • *IVD 0307 - Tumoral marker: PSA
  • *IVD 0102 - Rhesus (C, c, D, E, e)
  • *IVD 0103 - Anti-Kell
  • *IVD 0100 - Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups
  • *IVD 0101 - ABO system
  • *IVD 0405 - Pregnancy and ovulation
Source: EU Single Market Compliance Space (SMCS), retrieved 2026-06-23.
https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/free-search?text=2854

This page is an informational mirror of the official register. It is not affiliated with the European Commission. Always verify the current designation and scope against the official SMCS record before relying on it.