Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042197628

FEI Number

3042197628

Entity Name

DIMEDI.CO.LTD

City/State/Country

Wonju Gangwon, KR

Establishment Address

209ho, Wonju Venture Plaza, 130-2, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Republic of Korea, Wonju Gangwon 26365, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dimedi.Co.Ltd (Owner Number: 10094246)

Owner / Operator Contact Address

209ho, Wonju Venture Plaza, 130-2, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Republic of Korea, Wonju, KR-42 26365, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ZEROPSP TYPE-1 ZEROPSP TYPE-2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EAM	Screen, Intensifying, Radiographic	Radiology	Class 1	892.1960	2025-11-26

Official Correspondent

Seong-Jin Lee

US Agent Details

Mateo Carrasco Business: RFW LLC Email: info@afpharmaservice.com Phone: (407) 2849480

Related Public Records

Same Entity

Dimedi.Co.Ltd

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042197628. Last updated year: 2026. Please use registration number 3042197628 when referencing this establishment in official correspondence.