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DEMEDITEC DIAGNOSTICS GmbH

Germany · Kiel-Wellsee Schleswig-Holstein

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Australia — 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

pendingnot queried

USUnited StatesFDA openFDA

19listed device types

Class I 19Class II 0Class III 0

plus 21 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

16registered devices

Class II 16

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

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 2 3

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.

United States21 registration records, 0 510(k), 0 PMA

Brazil16 confirmed, 1 excluded

Manufacturer names merged into this page: DEMEDITEC DIAGNOSTICS GmbH · DEMEDITEC DIAGNOSTICS GMBH

FDA listed device types

showing 8 of 19

Antigen, Fluorescent Antibody Test, Schistosoma Mansoni 1Antisera, Cf, Parainfluenza Virus 1-4 1Respiratory Syncytial Virus - Elisa 1Radioimmunoassay, Estriol 1Radioimmunoassay, 17-Hydroxyprogesterone 1Radioimmunoassay, Immunoreactive Insulin 1Elisa, Trichinella Spiralis 1Radioimmunoassay, Androstenedione 1

Market	Identifier	Name	Class / date
BR	80836930144	Cortisol free in Saliva ELISA	Class II
BR	80836930145	DHEA free in Saliva ELISA	Class II
BR	80464810157	PROINSULINA	Class II

DEMEDITEC DIAGNOSTICS GmbH

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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