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ELCON Medical Instruments GmbH.

Germany · Tuttlingen Baden-Wurttemberg

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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

74listed device types

Class I 74Class II 0Class III 0

plus 74 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

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

SASaudi ArabiaSFDA

56registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

111active ARTG entries

Class I 110IIa 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

2registrations

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 States74 registration records, 0 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Saudi Arabia56 confirmed, 0 excluded

Manufacturer names merged into this page: ELCON MEDICAL INSTRUMENTS GMBH · ELCON Medical Instruments GmbH.

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80136990999	Instrumentos Cirúrgicos Sourcetank	Class I
BR	80136991002	Instrumentais Cirurgicos em Aço Sourcetank	Class I
BR	80136991000	Família de Instrumentais Sourcetank	Class I
SA	ME0000006228SFDAA00097	Screw Driver	—
SA	ME0000006228SFDAA00001	Spatula	—

ELCON Medical Instruments GmbH.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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