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ER TIBBI URUNLER SAGLIK HIZ. PAZ. VE DIS TIC. LTD. STI.

Türkiye

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

16listed device types

Class I 7Class II 8Class III 0unclassified 1

plus 16 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 2Class II 3

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

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 States16 registration records, 0 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Manufacturer names merged into this page: INCELER MEDIKAL SAGLIK HIZ. SAN. LTD. STI. · Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve Tic. A. S. · GEOTEK MEDIKAL VE SAGLIK HIZ. LTD. STI · GEOTEK MEDIKAL VE SAGLIK HIZ.LTD.STI · ER TIBBI URUNLER SAGLIK HIZ. PAZ. VE DIS TIC. LTD. STI.

FDA listed device types

showing 8 of 16

Endoscope Introducer Kit 1Transducer, Ultrasonic, Diagnostic 1Instrument, Biopsy 1Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) 1Drape, Surgical, Exempt 1I.V. Start Kit 1Foley Catheter Kit (Excludes Hiv Testing) 1Central Venous Catheter Dressing Change Kit 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80471700030	CÂNULA DUPLO LUMEM PARA ASPIRAÇÃO DE OÓCITOS	Class II
BR	80471700031	CÂNULA DE LUMEM SIMPLES PARA ASPIRAÇÃO DE OÓCITOS	Class II
BR	80471700029	DISPOSITIVO PARA BIÓPSIA MAXICORE-M	Class II

ER TIBBI URUNLER SAGLIK HIZ. PAZ. VE DIS TIC. LTD. STI.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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