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ORTOLOG MEDİKAL SANAYİ VE TİCARET A.Ş.

Türkiye · Yenimahalle Ankara · www.ortolog.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN TR-MF-000027137

This company has registrations in European Union, United States, United Kingdom, Brazil — 4 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

229UDI-DI device records

Class I 85Class IIb 126Class III 18

USUnited StatesFDA openFDA

1listed device types

Class I 1Class II 0Class III 0

plus 1 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class IIb 2

BRBrazilANVISA

6registered devices

Class I 6

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.

European Union229 raw hits, 0 excluded, 229 confirmed

United States1 registration records, 0 510(k), 0 PMA

United Kingdom2 confirmed, 0 excluded

Brazil6 confirmed, 0 excluded

Manufacturer names merged into this page: ORTOLOG MEDIKAL SANAYI VE TICARET A.S. · ORTOLOG MEDIKAL SAN. VE TIC. A.S. · ORTOLOG MEDIKAL SAN. VE TIC. A.&#350.

Same-named companies — This database also contains companies with near-identical names: ORTOLOG MEDIKAL SAN. VE TIC. A.Ş., ORTOLOG MEDIKAL SAN. VE TIC. A.S.. Company name alone cannot separate their registrations, so the figures below may include either.

Regulatory identity

EU manufacturer SRN: TR-MF-000027137
UK responsible person: United Orthopedic Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08682320051058	Ortholox UHMWPE Orthopedics Cerclage Band System (Ti. Locking-Low Profile) - 6.0 x 450mm	Class IIb
EU	08682320051096	Ortholox® UHMWPE Orthopedics Cerclage Band System (Ti. Locking-Low Profile) - 6.0 x 650mm	Class IIb
EU	08682320050655	Ortholox® Locking Attachment Plate Screw Box - Lid	Class I
EU	08682320050624	Ortholox® Locking Attachment Plate Screw Box(Empty)	Class I
UK	66932	Ortholox	Class IIb
UK	46647	Ortholox	Class IIb
BR	82251710001	Conjunto de instrumentos do Sistema de Bandas de Cerclagem Esterno Ort	Class I
BR	82251710002	Conjunto de instrumentos para deformidade do Sistema de Bandas de Cerc	Class I
BR	82251710003	Conjunto de instrumentos do Sistema de Bandas de Cerclagem Ortholox Or	Class I

ORTOLOG MEDİKAL SANAYİ VE TİCARET A.Ş.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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