Noul Co.,Ltd

Korea, Republic · Yongin-si · www.noul.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN KR-MF-000033621

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada — 5 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

IVD A 3IVD general 3

USUnited StatesFDA openFDA

6listed device types

Class I 6Class II 0Class III 0

plus 6 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

10registered device records

IVD A 4IVD general 6

BRBrazilANVISA

3registered devices

Class I 2Class 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

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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.

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 Union6 raw hits, 0 excluded, 6 confirmed

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

United Kingdom10 confirmed, 0 excluded

Brazil3 confirmed, 1 excluded

Manufacturer names merged into this page: Noul Co., Ltd. · NOUL CO., LTD.

Regulatory identity

EU manufacturer SRN: KR-MF-000033621
EU authorised representative: Medical Technology Promedt Consulting GmbH
UK responsible person: MT Promedt Consulting Ltd

Business registration

KRX ticker code: 376930
Registration status: Active
Incorporated: 2022-03-03

Business registration data from KRX KIND, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08800100120217	SafeFix™ CER	IVD A
EU	08800100120019	SafeFix	IVD A
EU	08800100100011	miLab™ Platform	IVD A
EU	18800100110017	miLab™ Cartridge MAL	IVD general
UK	58721	miLab™ Cartridge MAL	IVD general
UK	58721	miLab™ Cartridge BCM	IVD general
UK	58721	miLab™ Cartridge CER	IVD general
BR	82444370242	miLab Cartridge BCM	Class II
BR	82444370246	miLab Platform	Class I
BR	82444370241	SafeFix	Class I

Noul Co.,Ltd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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