Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023174629

FEI Number

3023174629

Entity Name

MEDITEC TECHNOLOGY COMPANY LIMITED

City/State/Country

Bac Ninh, VN

Establishment Address

Dai Dong - Hoan Son Industrial Zone, Dai Dong Commune, Bac Ninh 16000, VN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MEDITEC TECHNOLOGY COMPANY LIMITED (Owner Number: 10078880)

Owner / Operator Contact Address

Dai Dong - Hoan Son Industrial Zone, Dai Dong Commune, Bac Ninh, VN-56 16000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CONTAINER, SPECIMEN, NON-STERILE Syringe, piston SPECIMEN CONTAINER, Catheter, Straight

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2022-12-27
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2022-12-27
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2023-01-08
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2022-12-21

Official Correspondent

DUNG HOANG MINH

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

MEDITEC TECHNOLOGY 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-0004-2013	Cure Medical LLC	2	Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023174629. Last updated year: 2026. Please use registration number 3023174629 when referencing this establishment in official correspondence.