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Asset Medikal Tasarim San. ve Tic. A.S.

Türkiye · Istanbul · www.assetmedical.com

✓ Record-verifiedregistrations found in 7 marketsEU SRN TR-MF-000018584

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Australia, Hong Kong — 7 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

101UDI-DI device records

Class IIa 101

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 7 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

7registered device records

Class IIa 7

BRBrazilANVISA

12registered devices

Class I 4Class II 8

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

2active device licences

Class II 2

9 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

15active ARTG entries

IIa 12IIb 3

HKHong KongMDACS

1valid listings

Class II 1

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 Union114 raw hits, 13 excluded, 101 confirmed

United States7 registration records, 8 510(k), 0 PMA, 1 excluded

United Kingdom7 confirmed, 1 excluded

Brazil12 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: ASSET MEDIKAL TASARIM SAN. TIC. A.S. · LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN. TIC. LTD. STI · ASSET MEDIKAL TASARIM SAN. VE TIC. A. S. · ASSET MEDIKAL TASARIM SAN. VE TIC. AS · Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd. · ASSET MEDICAL TASARIM A.S.

Regulatory identity

EU manufacturer SRN: TR-MF-000018584
UK responsible person: Medes Ltd.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08699443580358	FlowArt	Class IIa
EU	08699443580020	FlowArt	Class IIa
EU	08699443581379	FlowArt	Class IIa
EU	08699443582147	Sol-Care™	Class IIa
UK	12170	FlowArt Sterile Infusion Therapy Devices - EXTENSION SETS	Class IIa
UK	35072	FlowArt Sterile Infusion Therapy Devices - FILTER SETS	Class IIa
UK	61141	Disinfecting Cap	Class IIa
US	K232987	FlowArt Valve for Vial Access	2024-06-26
US	K222889	FlowArt® Needle-Free Split Septum Valve	2023-01-20
US	K221473	Flowart	2022-09-26
BR	81319579006	BOMBA TIRA-LEITE ELÉTRICA LANSINOH	Class II
BR	80937159111	SOL-CARE Tampa Protetora com Álcool para Desinfecção de Conectores Sem	Class II
BR	80102512226	Conector para terapia de infusão estéril FlowArt® - Conjuntos de Exten	Class I
CA	105510	LANSINOH COMPACT SINGLE ELECTRIC BREAST PUMP	Class II
CA	91656	AFFINITY DOUBLE ELECTRIC BREAST PUMP	Class II

Asset Medikal Tasarim San. ve Tic. A.S.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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