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TST Rakor Tibbi Aletler San. ve Tic. Ltd

Türkiye · Istanbul · www.tstorthopedics.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN TR-MF-000017767

This company has registrations in European Union, Brazil, Australia, Hong Kong, Israel — 5 overseas markets. EU UDI-DI records ≥100, 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

≥100UDI-DI device records

Class IIb 100

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

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

62registered devices

Class I 60Class II 2

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

7active ARTG entries

Class I 1IIb 6

HKHong KongMDACS

1valid listings

Class III 1

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 Union7,464 raw hits, 0 excluded, 100 confirmed. Large result set — only the first 300 verified

Brazil62 confirmed, 0 excluded

Manufacturer names merged into this page: TST RAKOR T&#305.BBI ALETLER SAN. TIC. LTD. &#350.TI. · TST Rakor ve Tibbi Aletler San. ve Tic. Ltd. Sti. · TST RAKOR VE TIBBI ALETLER SANAYI VE TICARET LIMITED SIRKETI · TST Rakor ve Tibbi Aletler Sanayi ve Ticaret Ltd. Sti.

Regulatory identity

EU manufacturer SRN: TR-MF-000017767

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08680858485666	TST Cannulated Screws System	Class IIb
EU	08680858485659	TST Cannulated Screws System	Class IIb
EU	08680858485642	TST Cannulated Screws System	Class IIb
EU	08680858485635	TST Cannulated Screws System	Class IIb
BR	80865020024	DAF DYNAMIC MULTIAXIAL FIXATOR TST	Class I
BR	80865020025	UMEF ULTRA MODULAR EXTERNAL FIXADOR TST	Class I
BR	80865020026	ORTHO SUV FRAME TST	Class I

TST Rakor Tibbi Aletler San. ve Tic. Ltd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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