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DYNEX TECHNOLOGIES, spol. s r.o.

Czechia · Praha · www.dynex.cz

✓ Record-verifiedregistrations found in 7 marketsEU SRN US-MF-000014753

This company has registrations in European Union, United States, United Kingdom, Taiwan, Australia, Israel, Russia — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

17UDI-DI device records

IVD A 17

USUnited StatesFDA openFDA

3listed device types

Class I 3Class II 0Class III 0

plus 3 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

3registered device records

IVD A 2IVD general 1

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

IVD Class 1 8

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 1Class 2a 2

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union17 raw hits, 0 excluded, 17 confirmed

United States3 registration records, 1 510(k), 0 PMA, 2 excluded

United Kingdom3 confirmed, 0 excluded

Brazil0 confirmed, 1 excluded

Manufacturer names merged into this page: DYNEX TECHNOLOGIES, INC.

Regulatory identity

EU manufacturer SRN: US-MF-000014753
EU authorised representative: Acorn Regulatory Consultancy Services Ltd
UK responsible person: Dynex Technologies

Business registration

LEI: 315700X5EXX8G8K82798
Registration status: Active
Legal form: Společnost s ručením omezeným
Incorporated: 1992-12-21
Registration authority: Commercial Register, no. 48108731
Registry record updated: 2026-05-21

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12023 · K212769

FDA listed device types

Station, Pipetting And Diluting, For Clinical Use 1Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05060456180546	Revelation DSX Software	IVD A
EU	05060456180300	DSX Automated ELISA with 4 incubators and sample ID	IVD A
EU	05060456180010	DSX Automated ELISA System with 4 incubators	IVD A
EU	05060456180218	DSX Automated ELISA with 2 incubators and sample ID	IVD A
UK	56676	AGILITY Automated ELISA System	IVD general
UK	57862	Dynex Dynaread	IVD A
UK	17489	Dynex Dynawash Automatic	IVD A
US	K212769	DYNEX SmartPLEX MMRV IgG Assay Kit	2023-09-29

DYNEX TECHNOLOGIES, spol. s r.o.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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