Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043709866

FEI Number

3043709866

Entity Name

HANTECH (NINGBO) MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

No. 836 Yuhai East Road, Qianwan New District, Ningbo, Zhejiang Province, China, No. 2 Building, No. 39 Qiyuan Road,Qianwan New District, Ningbo, Zhejiang Province, China, Ningbo Zhejiang 315336, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hantech (Ningbo) Medical Technology Co., Ltd. (Owner Number: 10095073)

Owner / Operator Contact Address

No. 836 Yuhai East Road, Qianwan New District, Ningbo, Zhejiang Province, China, Ningbo, CN-ZJ 315336, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pre-filled 0.9% Normal Saline Flush Syringes Disposable Medical Safety Hypodermic Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2026-01-23
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-01-23

Official Correspondent

Rachel Jin

US Agent Details

Hong Hui Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (509) 5816099

Related Public Records

Same Entity

Hantech (Ningbo) Medical Technology Co., 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2011	Excelsior Medical Corp	2	Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
Z-0044-2007	Excelsior Medical Corp	2	0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

Similar Registrations

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3014421917	O&M Halyard, Inc.	Alpharetta, GA, US
3016413378	JIAXING TIANHE PHARMACEUTICAL CO., LTD.	Jiaxing Zhejiang, CN
3005934752	MEDXL INC	Pointe-Claire Quebec, CA
1911916	BECTON DICKINSON AND COMPANY	COLUMBUS, NE, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043709866. Last updated year: 2026. Please use registration number 3043709866 when referencing this establishment in official correspondence.