HomeTürkiyeAsset Medikal

Asset Medikal

Türkiye · Istanbul
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 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 7 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
9registered devices
Class I 2Class II 7
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
5 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
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.

United States7 registration records, 7 510(k), 0 PMA, 2 excluded
Brazil9 confirmed, 1 excluded
Manufacturer names merged into this page: ASSET MEDIKAL TASARIM SAN. TIC. A.S. · ASSET MEDIKAL TASARIM SAN. VE TIC. A. S. · ASSET MEDIKAL TASARIM SAN. VE TIC. AS

Company information

Country
Türkiye
City
Istanbul

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

12020 · K190806
12021 · K201872
22022 · K221473
12023 · K222889
12024 · K232987
12025 · K251715

FDA listed device types

Set, I.V. Fluid Transfer 1Set, Administration, Intravascular 1Stopcock, I.V. Set 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251715FlowArt® Vial Access Device Vented2025-10-14
USK232987FlowArt Valve for Vial Access2024-06-26
USK222889FlowArt® Needle-Free Split Septum Valve2023-01-20
BR80937159111SOL-CARE Tampa Protetora com Álcool para Desinfecção de Conectores SemClass II
BR80102512226Conector para terapia de infusão estéril FlowArt® - Conjuntos de ExtenClass I
BR81836879001FlowArt® ADAPTADOR DE BOLSAS E FRASCOS NEEDLE-FREEClass II

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