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Ministry of Industry and Trade of the Czech Republic

Czechia · Prague · mpo.cz

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

0UDI-DI device records

USUnited StatesFDA openFDA

18listed device types

Class I 8Class II 10Class III 0

plus 18 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

2registered devices

Class II 2

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

1active device licences

Class II 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 Union737 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States18 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil2 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: ICU Medical Czech Republic a. s. · Thuasne Czech Republic S.R.O · SMITHS MEDICAL CZECH REPUBLIC A.S. · SMITHS MEDICAL CZECH REPUBLIC

Business registration

Legal name: TPC INDUSTRY CZECH REPUBLIC a.s.
LEI: 315700NC3O0GWT0GLC84
Registration status: Active
Legal form: Akciová společnost
Incorporated: 2016-01-05
Registration authority: Commercial Register, no. 04690079
Registry record updated: 2026-04-28

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

FDA listed device types

showing 8 of 18

Needle, Conduction, Anesthetic (W/Wo Introducer) 1Tube, Tracheostomy (W/Wo Connector) 1Tube Tracheostomy And Tube Cuff 1Anesthesia Conduction Kit 1Attachment, Breathing, Positive End Expiratory Pressure 1Needle, Emergency Airway 1Needle, Spinal, Short Term 1Transducer, Blood-Pressure, Extravascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10150470007	CONJUNTO EPIDURAL MINIPACK PORTEX	Class II
BR	10150470275	CÂNULA PARA TRAQUEOSTOMIA BLUE LINE ULTRA COM BALÃO E DISPOSITIVO DE U	Class II
CA	92288	HEMODRAW KITS FOR ARTERIAL CLOSED BLOOD SAMPLING	Class II

Ministry of Industry and Trade of the Czech Republic

Registrations by market

How these numbers were verified

Company information

Business registration

FDA listed device types

Registration details (sample)

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