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IntroMedic Co., Ltd.

Korea, Republic · Seoul

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Russia — 7 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

1listed device types

Class I 0Class II 1Class III 0

plus 6 registration records and 11 510(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

6active device licences

Class II 6

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 2IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2b 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 States6 registration records, 11 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: IntroMedic Co., Ltd. · INTROMEDIC CO., LTD · INTROMEDIC CO., LTD.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252617	MiroCam® Capsule Endoscope System	2026-05-08
US	K180732	MiroCam Capsule Endoscope System	2018-11-08
US	K170438	MiroCam Capsule Endoscope System	2018-01-30
BR	80904019001	Endoscópio em Cápsula MiroCam® e Receptor MiroCam®	Class II
CA	77649	MIROCAM (CAPSULE ENDOSCOPE)	Class II
CA	84760	E.G. SCAN (GASTROSCOPE SYSTEM)	Class II
CA	86466	MIROCAM - CAPSULE ENDOSCOPE	Class II

IntroMedic 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)

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