Home›Türkiye›Geotek Medikal ve Saglik Hiz Tic. San. Ltd. Sti

Geotek Medikal ve Saglik Hiz Tic. San. Ltd. Sti

Türkiye · Ankara · www.geotekmedical.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN TR-PR-000039085

This company has registrations in European Union, United States, United Kingdom, Brazil, Israel — 5 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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

≥300UDI-DI device records

Class IIa 300

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

2listed device types

Class I 0Class II 2Class III 0

plus 2 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

13registered device records

Class IIa 12Class IIb 1

BRBrazilANVISA

16registered devices

Class I 1Class II 15

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

1registrations

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 Union2,352 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States2 registration records, 2 510(k), 0 PMA

United Kingdom13 confirmed, 0 excluded

Brazil16 confirmed, 0 excluded

Manufacturer names merged into this page: GEOTEK MEDIKAL VE SAGLIK HIZ. LTD. STI · Geotek Medikal ve Saglik Hizmetleri Tic.San.Ltd.Sti · GEOTEK MEDIKAL VE SAGLIK HIZ.LTD.STI

Regulatory identity

EU manufacturer SRN: TR-PR-000039085
UK responsible person: MCT Lifesciences Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08681672057237	TRUS Biopsy Kit	Class IIa
EU	08681672057220	TRUS Biopsy Kit	Class IIa
EU	08681672057213	TRUS Biopsy Kit	Class IIa
EU	08681672057206	TRUS Biopsy Kit	Class IIa
UK	46452	Stone Basket	Class IIa
UK	64326	MAXICORE Automatic Biopsy Gun	Class IIa
UK	35886	Breast Localization Needle	Class IIa
US	K223300	Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument	2023-04-21
US	K170741	GTK Disposable Needle Guides	2017-06-01
BR	80471700028	DISPOSITIVO MAXICORE-U	Class II
BR	80471700023	Cânula para marcação de nódulo	Class II
BR	80471700024	GUIA PARA BIÓPSIA ENDOCAVITÁRIA	Class II

Geotek Medikal ve Saglik Hiz Tic. San. Ltd. Sti

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies