Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007590959

FEI Number

3007590959

Entity Name

ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Tianchang Anhui, CN

Establishment Address

No 228, WeiYi Road, Economic Development Zone, Tianchang Anhui 239300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Anhui Tiankang Medical Technology Co., Ltd. (Owner Number: 10042273)

Owner / Operator Contact Address

No 228, WeiYi Road, Economic Development Zone, Tianchang, CN-AH 239300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191640

PMA Number

N/A

All Registered Proprietary Names

Sterile Disposable Syringe with Needle; Sterile Disposable Syringe with Safety Needle Sterile Disposable Needle; Sterile Disposable Safety Needle; Sterile Disposable Syringe; Prefilled syringe TK insulin syringe, safety insulin with/without retractable needle Fluid Dispensing Connector Safety insulin syringe Bifurcated needle Disposable syringe with permanently attached needle, safety syringe with permanently attached needle Disposable infusion set with needle; Disposable infusion set without needle; Disposable infusion set with safety needle IV Set with needle; IV set without needle; IV set with safety needle; IV set DEHP-Free Infusion set with latex; infusion set latex free

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-01-08
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2023-08-15
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2014-05-23
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-05-07
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2020-09-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-09-15
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2015-12-29
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2012-11-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-02-21
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2017-02-21
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2016-09-19
SCL	Allergen And Vaccine Delivery Needles	General Hospital	Class 2	880.5570	2023-06-16
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-08-09
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2022-08-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-11-11

Official Correspondent

Baodong Bai

US Agent Details

James H Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

Anhui Tiankang 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
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04
K163162	Jiangxi Hongda Medical Equipment Group , Ltd.	Sterile Hypodermic Safety Syringes for Single Use	2017-03-20
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-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-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-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

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3000214934	ALMAC PHARMA SERVICES LLC	Audubon, PA, US
3006850123	JAPAN IRRADIATION SERVICE CO., LTD	Naka-gun Ibaraki, JP
3029328631	PEGASUS IMPORTS	Houston, TX, US
3010621964	ATLAS MEDICAL PRODUCTS LLC	Hialeah, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007590959. Last updated year: 2026. Please use registration number 3007590959 when referencing this establishment in official correspondence.