Home›Korea, Republic›HI MEDICAL CO., LTD.

HI MEDICAL CO., LTD.

Korea, Republic · Seoul

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

pendingnot queried

USUnited StatesFDA openFDA

39listed device types

Class I 15Class II 21Class III 1unclassified 2

plus 45 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

3active device licences

Class II 3

6 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.

United States45 registration records, 5 510(k), 0 PMA, 45 excluded

Brazil1 confirmed, 13 excluded

Saudi Arabia0 confirmed, 6 excluded

Canada3 confirmed, 3 excluded

Manufacturer names merged into this page: HI MEDICAL CO., LTD. · HI-TEC MEDICAL GMBH · HI-TECH MEDICAL PRODUCTS LTD.

FDA 510(k) clearances by year

11986 · K862309

21995 · K952468

11997 · K955477

12014 · K141390

FDA listed device types

showing 8 of 39

Dressing, Wound, Hydrophilic 1Protector, Skin Pressure 1Applicator, Resin 1Syringe, Restorative And Impression Material 1Dressing, Wound, Occlusive 1Protector, Ostomy 1Crown, Preformed 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K141390	INTERMITTENT PNEUMATIC COMPRESSION DEVICE	2014-11-18
US	K955477	HI-TEC CO2 INSUFFLATOR TYPE 1300	1997-08-06
US	K952468	HI-LINE MEDICAL PHACOEMULSIFIER TIP	1995-08-24
BR	80451960106	NPH MEDICAL SERINGA DESCARTÁVEL COM AGULHA	Class II
CA	67679	ASPIRATORS - ENDOSCOPIC IRRIGATION	Class II
CA	67681	INSUFFLATORS/ HYSTEROSCOPIC	Class II
CA	67682	IRRIGATION/ DISTENSION SYSTEMS - ARTHROSCOPIC	Class II

HI MEDICAL CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies