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Mcube Technology Co., Ltd.

Korea, Republic · Seoul · www.mcubetech.co.kr

✓ Record-verifiedregistrations found in 11 marketsEU SRN KR-MF-000020590

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 11 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

6UDI-DI device records

Class IIa 6

USUnited StatesFDA openFDA

2listed device types

Class I 0Class II 2Class III 0

plus 6 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIa 1

BRBrazilANVISA

1registered devices

Class II 1

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

6 including historic records

TWTaiwanTFDA

6valid device licences

Class II 6

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

5valid listings

Class II 5

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 Union11 raw hits, 5 excluded, 6 confirmed

United States6 registration records, 6 510(k), 0 PMA

United Kingdom1 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: MCUBE TECHNOLOGY Co.,Ltd. · MCUBE TECHNOLOGY CO.,LTD. · MCUBE TECHNOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN: KR-MF-000020590
EU authorised representative: AR Experts B.V.
UK responsible person: de Smit Medical Systems Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08809458500054	CUBEScan	Class IIa
EU	08809458500023	CUBEScan	Class IIa
EU	08809458500115	CUBEScan	Class IIa
EU	08809458500085	CUBEScan	Class IIa
UK	41501	CUBEScan Bladder Volume Measurement System	Class IIa
US	K201995	CUBEScan BioCon-1100	2020-08-19
US	K200749	CUBEScan BioCon-900S	2020-05-19
US	K200548	CUBEScan BioCon-1100	2020-03-27
BR	80117580878	Bladder Volume Measurement System	Class II

Mcube Technology Co., Ltd.

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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