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SET Medikal San. Ve Tic. A.S.

Türkiye · Esenyurt/Istanbul · www.setmedikal.com.tr

✓ Record-verifiedregistrations found in 3 markets

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

4listed device types

Class I 1Class II 2Class III 1

plus 4 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

1registered devices

Class I 1

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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 Union2,564 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States4 registration records, 2 510(k), 0 PMA, 4 excluded

United Kingdom0 confirmed, 25 excluded

Brazil1 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI · SET MEDIKAL SANAYI VETICARET A.&#350..

Registration details (sample)

Market	Identifier	Name	Class / date
US	K210200	1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock	2021-05-14
US	K201284	Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use	2020-12-14
BR	10301160236	Seringa de Gasometria Set ®	Class I

SET Medikal San. Ve Tic. A.S.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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