Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015060216

FEI Number

3015060216

Entity Name

HANTECH MEDICAL DEVICE CO., LTD.

City/State/Country

Cixi Zhejiang, CN

Establishment Address

No.288, Sanheng Road, Changhe Industrial Park,Cixi, 315326, Ningbo, P. R. China, Cixi Zhejiang 315326, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hantech Medical Device Co., Ltd. (Owner Number: 10058745)

Owner / Operator Contact Address

No.288, Sanheng Road, Changhe Industrial Park,Cixi, 315326, Ningbo, P. R. China, Cixi, CN-ZJ 315326, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Precision Sampling Set Amniotic Membrane Perforators Disposable Medical Masks KenFlush KFS1000 PRE-FILLED SALINE FLUSH SYRINGE,10ML , ITEM 5079 PRE-FILLED SALINE FLUSH SYRINGE,5ML , ITEM 5078 Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS- 1005, PFS-1010) EndoActivator Tips Disposable Insulin Pen Needle Disposable Insulin Syringe Umbilical Cord Clamp Braun ThermoScan Lens Filters Disposable Medical Safety Hypodermic Needle Mixing Tips Arterial Blood Gas Samplers Safety Arterial Blood Gas Samplers Extension set (T-fitting) RM0752504

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2021-03-07
HGE	Amniotome	Obstetrics/Gynecology	Class 1	884.4530	2022-06-09
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-09-07
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2023-10-19
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2022-09-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-04-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-03-12
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2022-06-09
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2026-01-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-08-23
KCQ	Tube Impression And Matrix	Dental	Class 1	872.6570	2023-06-15
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2025-05-11
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2024-09-30

Official Correspondent

Rachel Jin

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Hantech Medical Device 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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
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-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
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

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3015084765	GUANG DONG EDA TECHNOLOGY CO., LTD.	Dongguan City Guangdong, CN
3009831876	MASIMO CORPORATION	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015060216. Last updated year: 2026. Please use registration number 3015060216 when referencing this establishment in official correspondence.