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Alpinion Medical Systems Co.,Ltd.

✓ Record-verifiedregistrations found in 9 marketsEU SRN KR-MF-000012961

This company has registrations in European Union, United States, United Kingdom, Canada, Taiwan, Singapore, Australia, Israel, Russia — 9 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

13UDI-DI device records

Class IIa 13

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 38 registration records and 26 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class IIa 3

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

6active device licences

Class III 6

18 including historic records

TWTaiwanTFDA

13valid device licences

Class II 13

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

6active registrations

Class 2a 6

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 Union13 raw hits, 0 excluded, 13 confirmed

United States38 registration records, 26 510(k), 0 PMA, 1 excluded

United Kingdom3 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: ALPINION MEDICAL SYSTEMS Co., Ltd. · ALPINION MEDICAL SYSTEMS CO., LTD.

Regulatory identity

EU manufacturer SRN: KR-MF-000012961
EU authorised representative: Alpinion Medical Deutschland GmbH
UK responsible person: Physiquipe Limited
Exhibition record: CMEF 87th (Spring 2023, Shanghai)

FDA 510(k) clearances by year

12011

52012

22013

22014

12015

22016

12017

32018

12019

22020

22021

32022

12023

FDA listed device types

System, Imaging, Pulsed Doppler, Ultrasonic 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08800013531001	Minisono C1-6	Class IIa
EU	08800013530004	Minisono L3-12	Class IIa
EU	08800013526007	E-CUBE i7	Class IIa
EU	08800013520005	E-CUBE 5	Class IIa
UK	40768	1-5MHz Phased Array Transducer	Class IIa
UK	40761	Ultrasound Imaging system	Class IIa
UK	40771	3-10MHz Endocavity Transducer	Class IIa
US	K223564	X-CUBE 50, X-CUBE 60	2023-04-17
US	K221093	X-CUBE 70, X-CUBE 90	2022-10-14
US	K220857	X-CUBE 50, X-CUBE 60	2022-10-13
CA	91972	E-CUBE INNO DIAGNOSTIC ULTRASOUND SYSTEM	Class III
CA	92020	E-CUBE 9 DIAGNOSTIC ULTRASOUND SYSTEM	Class III
CA	92105	E-CUBE 7 ULTRASOUND SYSTEM	Class III