SAEHAN CORPORATION

Korea, Republic · Changwon Gyeongnam

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Australia — 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

10listed device types

Class I 9Class II 1Class III 0

plus 10 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

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

2active ARTG entries

Class I 2

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 States10 registration records, 1 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: SAEHAN CORPORATION

FDA 510(k) clearances by year

12005 · K052309

FDA listed device types

showing 8 of 10

Exerciser, Non-Measuring 1Discriminator, Two-Point 1Dynamometer, Nonpowered 1Gauge, Depth 1Pinwheel 1Tape, Measuring, Rulers And Calipers 1Components, Exercise 1Apparatus, Traction, Non-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K052309	DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006	2005-09-27
BR	82531170001	DINAMOMETRO SAEHAN KITS DE AVALIAÇÃO HIDRÁULICOS	Class I
BR	82531170004	DINAMOMETRO SAEHAN HIDRÁULICOS	Class I
BR	82531170002	DINAMOMETRO SAEHAN KITS DE AVALIAÇÃO MECÂNICOS	Class I

SAEHAN CORPORATION

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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