Hdi, Inc.

Korea, Republic · Seongnam-Si Gyeonggi

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Israel, Russia — 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

pendingnot queried

USUnited StatesFDA openFDA

18listed device types

Class I 15Class II 3Class III 0

plus 17 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

18registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

5valid device licences

Class I 4Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 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.

United States17 registration records, 2 510(k), 0 PMA

Saudi Arabia18 confirmed, 0 excluded

Manufacturer names merged into this page: HDI INC. · HDI Inc

FDA 510(k) clearances by year

22022 · K222741

FDA listed device types

showing 8 of 18

Preparer, Root Canal Endodontic 1Applicator, Resin 1Tray, Fluoride, Disposable 1Tray, Impression, Preformed 1Gag, Mouth 1Dam, Rubber 1Floss, Dental 1Cleaner, Ultrasonic, Medical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K222741	DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)	2022-11-07
US	K213339	DENU Composite Resin, DENU Flow Resin	2022-09-23
SA	ME0000004378SFDAA00014	Denu GingiCord	—
SA	ME0000004378SFDAA00011	Denu Putty Set	—

Hdi, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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