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Home›Türkiye›Smart Alfa Teknoloji San. Ve Tic. A.S.

Smart Alfa Teknoloji San. Ve Tic. A.S.

Türkiye · Ankara
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Australia — 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
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 3 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
11registered devices
Class II 11
12 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
1active ARTG entries
IIa 1
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.

Australia, Saudi Arabia: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.

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 States3 registration records, 2 510(k), 0 PMA, 2 excluded
Brazil11 confirmed, 1 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 · XERA Medikal Sistemleri ve Teknoloji Ltd. Sti. · MATEK MEDIKAL AYGITLAR TEKNOLOJI SAN. VE TIC. A.S · SEMIKAL TEKNOLOJI SANAYI VE TICARET A.S · Medikal 2000 Tibbi Cihazlar Ve Ileri Teknoloji San.Tic.A.S

Company information

Country
Türkiye
City
Ankara

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12025 · K250818
12026 · K260234

FDA listed device types

Ultrasound Guided Nerve Block Assist 1Uroflowmeter 1System, X-Ray, Stationary 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260234MSK Go2026-05-21
USK250818Nerveblox2025-08-15
BR83058639001Cânula de Biópsia Semi automática com CoaxialClass II
BR83058639002Cânula de Biópsia CoaxialClass II
BR83058639003Cânula de Biópsia Intra Óssea ManualClass II

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