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SMART ALFA TEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI

Türkiye · Ankara

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 3 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

pendingnot queried

USUnited StatesFDA openFDA

9listed device types

Class I 3Class II 6Class III 0

plus 7 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class I 1Class II 11

13 including historic records

SASaudi ArabiaSFDA

14registered 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.

United States7 registration records, 2 510(k), 0 PMA, 1 excluded

Brazil12 confirmed, 0 excluded

Saudi Arabia14 confirmed, 1 excluded

Manufacturer names merged into this page: ORUBA MEDIKAL TEKNOLOJI ARGE IC VE DIS TICARET ANONIM SIRKET · SMART ALFA TEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI · 3BFAB TEKNOLOJI ANONIM SIRKETI · XERA Medikal Sistemleri ve Teknoloji Ltd. Sti. · MATEK MEDIKAL AYGITLAR TEKNOLOJI SAN. VE TIC. A.S · BERIKA TEKNOLOJI MEDIKAL IMALAT ITHALAT IHRACAT TICARET LTD. STI.

FDA 510(k) clearances by year

12025 · K250818

12026 · K260234

FDA listed device types

showing 8 of 9

Ultrasound Guided Nerve Block Assist 1Uroflowmeter 1Additively Manufactured, Preformed, Resin Denture Tooth 1Resin, Denture, Relining, Repairing, Rebasing 1Material, Tooth Shade, Resin 1System, X-Ray, Stationary 1Accessories, Implant, Dental, Endosseous 1Protector, Dental 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260234	MSK Go	2026-05-21
US	K250818	Nerveblox	2025-08-15
BR	83058639001	Cânula de Biópsia Semi automática com Coaxial	Class II
BR	83058639002	Cânula de Biópsia Coaxial	Class II
BR	83058639003	Cânula de Biópsia Intra Óssea Manual	Class II
SA	ME0000005708SFDAA00001	Stretcher	—
SA	ME0000005708SFDAA00002	Examination Table	—

SMART ALFA TEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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