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TRUEMED Medical Ürünler Üretim ve Pazarlama A.S

Türkiye · Ümraniye - Istanbul · www.truemed.com.tr

✓ Record-verifiedregistrations found in 2 marketsEU SRN TR-MF-000033144

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

29UDI-DI device records

Class IIb 29

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class IIb 4

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 Union29 raw hits, 0 excluded, 29 confirmed

United States0 registration records, 0 510(k), 0 PMA, 1 excluded

United Kingdom4 confirmed, 0 excluded

Regulatory identity

EU manufacturer SRN: TR-MF-000033144
UK responsible person: Epangea Medical Import and Export Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08680734670834	TRUEMED	Class IIb
EU	08680734670827	TRUEMED	Class IIb
EU	08680734670810	TRUEMED	Class IIb
EU	08680734670803	TRUEMED	Class IIb
UK	33187	Distal Screw for TrueNail Anti-Rotation Proximal Femoral Short Nail, Ti, Hexagonal Recess, Ø5x30mm	Class IIb
UK	55851	Locking Elastic Nail, Ti, 1.5x440mm	Class IIb
UK	66947	Cancellous Screw (16mm threaded, Self-tapping, locking), Ti, Ø6.5x30mm	Class IIb

TRUEMED Medical Ürünler Üretim ve Pazarlama A.S

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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