Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043532714

FEI Number

3043532714

Entity Name

OPTIMEDI CO., LTD.

City/State/Country

Goyang-si Gyeonggi, KR

Establishment Address

73 Samwon-ro, Deogyang-gu, Goyang-si Gyeonggi 10550, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Optimedi Co., Ltd. (Owner Number: 10095013)

Owner / Operator Contact Address

73 Samwon-ro, Deogyang-gu, Goyang-si, KR-41 10550, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OP-M101, OP-M102, OP-M103, OP-M104, OP-M105, OP-M106, OP-M107, OP-M108, OP-M109, OP-M110 OP-M111, OP-M112, OP-M113, OP-M114 OP-FC-23-120-B1, OP-FC-23-160-B1, OP-FC-23-180-B1, OP-FC-23-230-B1 OP-FC-23-120-A2, OP-FC-23-160-A2, OP-FC-23-180-A2, OP-FC-23-230-A2 OP-FC-23-120-B0, OP-FC-23-160-B0, OP-FC-23-180-B0, OP-FC-23-230-B0 OP-FC-18-120-B0, OP-FC-18-160-B0, OP-FC-18-180-B0, OP-FC-18-230-B0 OP-FC-23-120-B2, OP-FC-23-160-B2, OP-FC-23-180-B2, OP-FC-23-230-B2 OP-FC-23-120-A1, OP-FC-23-160-A1, OP-FC-23-180-A1, OP-FC-23-230-A1 OP-FC-18-120-B1, OP-FC-18-160-B1, OP-FC-18-180-B1, OP-FC-18-230-B1 OP-FC-21-120-C0, OP-FC-21-160-C0, OP-FC-21-180-C0, OP-FC-21-230-C0 OP-FC-18-120-A1, OP-FC-18-160-A1, OP-FC-18-180-A1, OP-FC-18-230-A1 OP-FC-21-120-B1, OP-FC-21-160-B1, OP-FC-21-180-B1, OP-FC-21-230-B1 OP-FC-21-120-A0, OP-FC-21-160-A0, OP-FC-21-180-A0, OP-FC-21-230-A0 OP-FC-23-120-C2, OP-FC-23-160-C2, OP-FC-23-180-C2, OP-FC-23-230-C2 OP-FC-21-120-B2, OP-FC-21-160-B2, OP-FC-21-180-B2, OP-FC-21-230-B2 OP-FC-21-120-B0, OP-FC-21-160-B0, OP-FC-21-180-B0, OP-FC-21-230-B0 OP-FC-23-120-C0, OP-FC-23-160-C0, OP-FC-23-180-C0, OP-FC-23-230-C0 OP-FC-23-120-A0, OP-FC-23-160-A0, OP-FC-23-180-A0, OP-FC-23-230-A0 OP-FC-18-120-C0, OP-FC-18-160-C0, OP-FC-18-180-C0, OP-FC-18-230-C0 OP-FC-21-120-C2, OP-FC-21-160-C2, OP-FC-21-180-C2, OP-FC-21-230-C2 OP-FC-18-120-A2, OP-FC-18-160-A2, OP-FC-18-180-A2, OP-FC-18-230-A2 OP-FC-23-120-C1, OP-FC-23-180-C1, OP-FC-23-180-C1, OP-FC-23-230-C1 OP-FC-18-120-B2, OP-FC-18-160-B2, OP-FC-18-180-B2, OP-FC-18-230-B2 OP-FC-18-120-C2, OP-FC-18-160-C2, OP-FC-18-180-C2, OP-FC-18-230-C2 OP-FC-18-120-A0, OP-FC-18-160-A0, OP-FC-18-180-A0, OP-FC-18-230-A0

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2026-01-15
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2026-01-15

Official Correspondent

Jaeil Seock

US Agent Details

Jung Ryun Ahn Business: KMC USA, Inc Email: kmc.usa@kmcerti.com Phone: (646) 3576058

Related Public Records

Same Entity

Optimedi Co., Ltd.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3043473562	NADIA-HEALTH INC	Durham, NC, US
3038913749	INVENTEUR, LLC	Saint Petersburg, FL, US
9681702	BATRIK MEDICAL MANUFACTURING INC.	Lachine Quebec, CA
3014926389	Jiangsu JianYu Health Medical Co., Ltd	Changzhou City Jiangsu, CN
3004930567	SUZHOU SUNING UNDERPAD CO., LTD.	SUZHOU, JIANGSU PROVINCE, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043532714. Last updated year: 2026. Please use registration number 3043532714 when referencing this establishment in official correspondence.