Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029913483

FEI Number

3029913483

Entity Name

DIMEDI KOREA INC

City/State/Country

Busan, KR

Establishment Address

Rm.201,1 Mandeok 3-ro 16beon-gil, Buk-gu, Busan, Busan 46570, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DIMEDI KOREA INC (Owner Number: 10094323)

Owner / Operator Contact Address

Rm.201,1 Mandeok 3-ro 16beon-gil, Buk-gu, Busan, Busan, KR-26 46570, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232238

PMA Number

N/A

All Registered Proprietary Names

GOYO SLIM FIT MOUTH GUARD GOYO Mouthpiece S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2025-11-23

Official Correspondent

DONGHUN LEE

US Agent Details

HUICHAO LEE Business: SMB USA LLC. Email: info@smbusa.com Phone: (734) 6297552

Related Public Records

Same Entity

DIMEDI KOREA INC

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029913483. Last updated year: 2026. Please use registration number 3029913483 when referencing this establishment in official correspondence.