LowTem Co., Ltd.

Korea, Republic · Daegu · www.lowtem.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN KR-MF-000016177

This company has registrations in European Union, United States, Australia, Russia — 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

34UDI-DI device records

Class IIa 27Class IIb 7

USUnited StatesFDA openFDA

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 Union34 raw hits, 0 excluded, 34 confirmed

United States0 registration records, 1 510(k), 0 PMA

Regulatory identity

EU manufacturer SRN: KR-MF-000016177
EU authorised representative: Meridius Medical Europe Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08809416740683	PLUSMA 120	Class IIa
EU	08809416740539	PROHS 120D	Class IIa
EU	08809416740546	PROHS 120M	Class IIa
EU	08809416740645	LOWTEM Crystal 120D	Class IIa
US	K231893	LOWTEM Crystal 120	2024-09-18

LowTem Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

Registration details (sample)

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