Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013684328

FEI Number

3013684328

Entity Name

IntroMedic Co., Ltd.

City/State/Country

Anyang-si Gyeonggi, KR

Establishment Address

F-RTEK 4F, 11-25, Simin-daero 327 beon-gil, Dongan-gu, Anyang-si Gyeonggi 14055, KR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

IntroMedic Co., Ltd. (Owner Number: 10027343)

Owner / Operator Contact Address

Suite 1105 1106, E&C Dream Tower 6 Cha Guro Dong, Guro Gu, Seoul, KR-11 08375, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180732

PMA Number

N/A

All Registered Proprietary Names

MiroCam Capsule Endoscope System MiroCam Capsule: MC2000-B MiroCam Receiver: MR2000 Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L) MiroCam Software: MiroView U 4 MiroCam Receiver: MR2000 Data Cable / Data Belt: MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L) MiroCam Software: MiroView U 4 MiroCam Capsule: MC1600-B MiroCam Capsule Endoscope System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule	Gastroenterology, Urology	Class 2	876.1300	2018-01-31
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule	Gastroenterology, Urology	Class 2	876.1300	2018-11-13

Official Correspondent

GuYeon Jung

US Agent Details

Minsung Kim Business: IntroMedic America Inc. Email: diego@intromedic.com Phone: (929) 2259154

Related Public Records

Same Entity

IntroMedic Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007244127	INTROMEDIC CO., LTD	Seoul, KR

Similar Registrations

Registration Number	Establishment Name	Location
8010047	OLYMPUS MEDICAL SYSTEMS CORP.	HACHIOJI-SHI Tokyo, JP
3007244127	INTROMEDIC CO., LTD	Seoul, KR
3002808148	SHIRAKAWA OLYMPUS CO., LTD.	NISHISHIRAKAWA-GUN Fukushima, JP
9710107	GIVEN IMAGING LTD.	Yoqneam Northern, IL
2518897	PENTAX of America, Inc.	MONTVALE, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013684328. Last updated year: 2026. Please use registration number 3013684328 when referencing this establishment in official correspondence.