Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027694073

FEI Number

3027694073

Entity Name

TOP-TEK TECHNOLOGY (VIETNAM) COMPANY LIMITED

City/State/Country

Thu Dau Mot Binh Duong, VN

Establishment Address

5Vsip II Street No 7, Viet Nam-Singapore II Industrial Zone, Binh Duon -Urban-Service Industrial Complex Area, Hoa Phu Ward, Thu Dau Mot Binh Duong 820000, VN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

TOP-TEK TECHNOLOGY (VIETNAM) COMPANY LIMITED (Owner Number: 10094482)

Owner / Operator Contact Address

5Vsip II Street No 7, Viet Nam-Singapore II Industrial Zone, Binh Duon -Urban-Service Industrial Complex Area, Hoa Phu Ward, Thu Dau Mot, VN-57 820000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190054

PMA Number

N/A

All Registered Proprietary Names

QIDILA 1ml/cc Disposable Syringe with 31G 1/4" (6mm) Needle QIDILA 1ml/cc Disposable Syringe with 30G 5/16" (8mm) Needle QIDILA 1ml/cc Disposable Syringe with 31G 5/16" (8mm) Needle YVTYVT U-100 1ml/cc Syringe with 30G 5/16" (8mm) Needle YVTYVT U-100 1ml/cc Syringe with 31G 5/16" (8mm) Needle QIDILA 1ml/cc Disposable Syringe with 30G 1/2" (12.7mm) Needle YVTYVT U-100 1ml/cc Syringe with 31G 1/4" (6mm) Needle QIDILA 1ml/cc Disposable Syringe with 29G 1/2" (12.7mm) Needle YVTYVT U-100 1ml/cc Syringe with 29G 1/2" (12.7mm) Needle YVTYVT U-100 0.5ml/cc Syringe with 30G 5/16" (8mm) Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-12-10

Official Correspondent

Jack Wang

US Agent Details

CJ frederick Email: cj.frederick@therabodycorp.com Phone: (310) 5708341

Related Public Records

Same Entity

TOP-TEK TECHNOLOGY (VIETNAM) COMPANY LIMITED

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
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3029328631	PEGASUS IMPORTS	Houston, TX, US
3021067373	VVT MED Ltd	Kfar Saba Central, IL
3009249481	JMS Co.,Ltd. Miyoshi Plant	Miyoshi Hiroshima, JP
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027694073. Last updated year: 2026. Please use registration number 3027694073 when referencing this establishment in official correspondence.