Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034205711

FEI Number

3034205711

Entity Name

HUIDA (VIETNAM) MEDICAL INSTRUMENTS COMPANY LIMITED

City/State/Country

THUY NGUYEN CITY Hai Phong, VN

Establishment Address

LOT CN8.2 and 5-2(FACTORY-OFFICE FOR RENT OF HAI PHONG INDUSTRIAL CONSTRUCTION INVESTMENT JOINT STOCK COMPANY), NAM CAU KIEN INDUSTRIAL PARK, HOANG LAM COMMUNE, THUY NGUYEN CITY Hai Phong 180000, VN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Huida (Vietnam) Medical Instruments Company Limited (Owner Number: 10092142)

Owner / Operator Contact Address

LOT CN8.2 and 5-2(FACTORY-OFFICE FOR RENT OF HAI PHONG INDUSTRIAL CONSTRUCTION INVESTMENT JOINT STOCK COMPANY), NAM CAU KIEN INDUSTRIAL PARK, HOANG LAM COMMUNE, THUY NGUYEN CITY, VN-HP 180000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Non-sterile Transfer Pipette Embedding Cassette Sterile Pasteur Pipette Microscope slide coversli

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2025-12-17
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2025-12-17
GJW	Pipette, Pasteur	Hematology	Class 1	864.6160	2025-12-17
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2024-12-09

Official Correspondent

Cathy Yin

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Huida (Vietnam) Medical Instruments Company Limited

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034205711. Last updated year: 2026. Please use registration number 3034205711 when referencing this establishment in official correspondence.