MEDICORE CO.LTD.

Korea, Republic · Seongnam-Si Gyunggi-Do · www.medi-core.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN KR-MF-000041156

This company has registrations in European Union, United States, United Kingdom, Taiwan, Israel — 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

2UDI-DI device records

Class IIa 2

USUnited StatesFDA openFDA

3listed device types

Class I 2Class II 1Class III 0

plus 4 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Custom-made 1

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

3valid device licences

Class I 1Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 Union2 raw hits, 0 excluded, 2 confirmed

United States4 registration records, 6 510(k), 0 PMA

United Kingdom1 confirmed, 0 excluded

Manufacturer names merged into this page: MEDICORE CO., LTD. · MEDICORE CO. LTD.

Regulatory identity

EU manufacturer SRN: KR-MF-000041156
EU authorised representative: MedSystem s.r.o.
UK responsible person: Thermal Health Ltd

FDA 510(k) clearances by year

11981 · K810681

11988 · K880869

11999 · K983430

12007 · K073323

12011 · K110374

12021 · K212412

FDA listed device types

Irrigator, Sinus 1System, Telethermographic (Adjunctive Use) 1Plethysmograph, Photoelectric, Pneumatic Or Hydraulic 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08800021400047	Medicore Co., Ltd	Class IIa
EU	08800021400009	Medicore Co., Ltd	Class IIa
UK	40803	IRIS-XP Infrared Thermographic Imaging System	Custom-made
US	K212412	IRIS-XP	2021-09-13
US	K110374	MAX PULSE SYSTEM	2011-06-13
US	K073323	SA-3000P	2007-11-29

MEDICORE 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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