Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025306483

FEI Number

3025306483

Entity Name

OPENM INC.

City/State/Country

Yuseong-gu Daejeon, KR

Establishment Address

413, Expo-ro, Yuseong-gu Daejeon 34051, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

openM inc. (Owner Number: 10086632)

Owner / Operator Contact Address

413, Expo-ro, Yuseong-gu, KR-30 34051, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OPENCAST (Model name: CM-03, CM-04, CM-05, CM-06, CM-07, CM-08) OPENCAST (Model name: SA-S, SA-M, SA-L, LA-S, LA-M, LA-L, SL-S, SL-M, SL-L, DH-S)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2022-11-28

Official Correspondent

No official correspondent registered.

US Agent Details

David Hyun Jun Paek Email: dpaek.rennes@gmail.com Phone: (818) 9030660

Related Public Records

Same Entity

openM inc.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3009067117	Posthorax Inc.	Clearwater, FL, US
3010195489	TOYO RESIN CORPORATION	FUJI Shizuoka, JP
3004740112	OVIK Health	Columbus, NC, US
2182345	BIRD & CRONIN, LLC	Eagan, MN, US
3017896419	FESUN SHANGHAI CO., LTD.	shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025306483. Last updated year: 2026. Please use registration number 3025306483 when referencing this establishment in official correspondence.