Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020777598

FEI Number

3020777598

Entity Name

DIEN QUANG HIGH TECH COMPANY LIMITED

City/State/Country

Ho Chi Minh, VN

Establishment Address

Lot HT 2-2, D2 Street, High Tech Park, Tang Nhon Phu Ward, Ho Chi Minh 700000, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DIEN QUANG HIGH TECH COMPANY LTD. (Owner Number: 10083000)

Owner / Operator Contact Address

Lot HT-2-2, D2 Street, High Tech Park, Tang Nhon Phu Ward, Ho Chi Minh, VN-NOTA 700000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EAR NOSE AND THROAT Enema bucket sets Penlight Pill Crusher Pill crusher & splitter combo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2024-08-22
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2021-11-23
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2023-04-10
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2023-03-07

Official Correspondent

No official correspondent registered.

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@Simconintl.Com Phone: (847) 9492290

Related Public Records

Same Entity

DIEN QUANG HIGH TECH COMPANY LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020777598. Last updated year: 2026. Please use registration number 3020777598 when referencing this establishment in official correspondence.