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ARTROTEK TIBBI MALZEME SANAYI VE TIC LTD

Türkiye · Seyhan Adana · www.artrotek.com.tr

✓ Record-verifiedregistrations found in 2 marketsEU SRN TR-MF-000032525

This company has registrations in European Union, United Kingdom — 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

24UDI-DI device records

Class IIb 24

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class IIa 2

BRBrazilANVISA

0registered devices

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 Union24 raw hits, 0 excluded, 24 confirmed

United Kingdom2 confirmed, 0 excluded

Regulatory identity

EU manufacturer SRN: TR-MF-000032525
UK responsible person: Joint Operations (UK) LLP

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08682520470239	ARTROLINE	Class IIb
EU	08682520470222	ARTROLINE	Class IIb
EU	08682520470215	ARTROLINE	Class IIb
EU	08682520470208	ARTROLINE	Class IIb
UK	57789	ARTROLINE 2.4 PASSING PIN DRILL TIP	Class IIa
UK	57874	ARTROLINE INTERFERANCE SCREW NITINOL GUIDE WIRE 0,8 MM	Class IIa

ARTROTEK TIBBI MALZEME SANAYI VE TIC LTD

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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