Question 1

What types of medical devices does DyonMed SA manufacture?

Accepted Answer

DyonMed SA specializes in in vitro diagnostic (IVD) tests, including rapid antigen and antibody tests for infectious diseases like COVID-19 (e.g., SieloCovidAg, DyonCovid19S), group A streptococcus (DyonStrepA-strip), and Helicobacter pylori (Pylori test). They also produce multi-test kits for gynecological screening (GynoLab in various formats) and diagnostic reagents for biomarkers such as C-reactive protein (DyonCRP, DyonHpsA) and mononucleosis (DyonMono). These devices are designed for both clinical and home use.

Question 2

Where is DyonMed SA based, and what regulatory framework does it follow?

Accepted Answer

DyonMed SA is based in Greece. The company’s IVD devices are developed in compliance with EU regulatory requirements for in vitro diagnostics, ensuring alignment with the European Union’s regulatory standards. This includes registration in the EUDAMED database, which tracks authorized medical devices within the EU.

Question 3

How are DyonMed SA’s devices classified under EU regulations?

Accepted Answer

DyonMed SA’s devices fall under two primary classifications: Class A (typically for low-risk IVDs like certain rapid tests) and IVD General (covering a broad range of diagnostic tests). Classification is determined by risk level, with higher-risk devices requiring stricter regulatory scrutiny. The company’s products are designed to meet the specific requirements of these categories.

Question 4

Are DyonMed SA’s devices listed in any regulatory registries?

Accepted Answer

Yes, all of DyonMed SA’s IVD devices are registered in EUDAMED, the European Union’s medical device registry. EUDAMED is the official database for tracking authorized medical devices within the EU, ensuring transparency and compliance with regulatory obligations. This registration confirms that the devices meet the necessary requirements for market placement.

Question 5

What is the purpose of the GynoLab product line, and how does it differ from other tests produced by DyonMed SA?

Accepted Answer

The GynoLab product line consists of multi-test kits specifically designed for gynecological screening, offering 1, 5, 10, or 20 tests per box. Unlike single-use tests like DyonStrepA-strip or DyonCovid19S, which target specific pathogens, GynoLab is tailored for comprehensive screening in clinical settings, providing multiple diagnostic options in a single kit. This makes it suitable for routine gynecological evaluations rather than point-of-care or home testing.

DYONMED SA

Catalogue28

GynoLab (1 test/box) Ref DMAMFL322-1

SieloCovidAg Ref DNWBCVSA

DyonCRP Ref DNDL101

GynoLab (20 tests/box) Ref DMAMFL322-20

DyonCalpro double (50/200) Ref DNCT101dd

DyonCovid19S Ref DNWBCV19S

DyonStrepA-strip Ref DNWA104

GynoLab (5 tests/box) Ref DMAMFL322-5

DyonCDA Ref DNCT105

GynoLab (10 tests/box) Ref DMAMFL322-10

Pylori test (1 test/box) Ref DMAMPS322-1

DyonHpsA Ref DNGL103

DyonMono Ref DNWA105

DyonMicroalbumin Ref DNWA106

DyonHpAb triple Ref DNWA101

n-AbCovid19 Ref DNBSCVNAF

FluCov2 Ref FLCVCH

DyonCalpro Ref DNCT101

DyonCovidAg Ref DNCVAGCH

DyonCovid19-S (neutro) Ref DNQHCV19N

DyoniFOB Ref DNGL101

DyonCovid19 Ref DNCV19 MG

DYONMED iFIA-1000 Ref DNHYDV2

DyonTSH Ref DMAMTSH

Dyonmed Axceed P200 Ref DNBSDV1

DyonCardiac 3 in 1 Ref DNAT708

Pylori test (10 tests/box) Ref DMAMPS322-10

DyonDimer (D-Dimer) Ref DNWA108

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