Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029915542

FEI Number

3029915542

Entity Name

HUONS MEDITECH CO., LTD

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

#216~219, 314, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea, Seongnam-si Gyeonggi 13201, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Huons USA (Owner Number: 10088996)

Owner / Operator Contact Address

200 Spectrum Center Drive, Ste 4036, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K131721

PMA Number

N/A

All Registered Proprietary Names

ASADAL-M1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2023-10-31

Official Correspondent

No official correspondent registered.

US Agent Details

Taehyung Kim Business: Edward Email: birdie84@huonsus.com Phone: (949) 4910649

Related Public Records

Same Entity

Huons USA

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3002807616	MEDISPEC, LTD.	YEHUD Central, IL
1061158	STORZ MEDICAL AMERICA, INC.	Kennesaw, GA, US
9613347	STORZ MEDICAL AG	TAEGERWILEN Thurgau, CH
9611388	DORNIER MEDTECH GMBH	WESSLING Bavaria, DE
3017140415	INITIA, LTD.	Petah Tikva Central, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029915542. Last updated year: 2026. Please use registration number 3029915542 when referencing this establishment in official correspondence.