Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014570560

FEI Number

3014570560

Entity Name

JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD

City/State/Country

Yancheng Jiangsu, CN

Establishment Address

Xituan Industrial Park, Dafeng District, Yancheng Jiangsu 224125, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Micsafe Medical Technology Co., Ltd (Owner Number: 10060296)

Owner / Operator Contact Address

Xituan Industrial Park, Dafeng District, Yancheng, CN-JS 224125, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181426

PMA Number

N/A

All Registered Proprietary Names

Blood Collection needle holder Safety Blood Collection needle holder Insulin syringe Insulin Syringe with Safety Retractable GLUCO-CARE Insulin Syringes 1ml/cc, 27G x 1/2"(12.7mm) GLUCO-CARE Insulin Syringes 0.5ml/cc, 30G x 5/16"(8mm); GLUCO-CARE Insulin Syringes 1ml/cc, 31g x 5/16"(8mm) ONE-CARE® Insulin Safety Syringe,1mL, 29G x 1/2; ONE-CARE TB Safety Syringe, 1mL, 27G x 1/2 GLUCO-CARE Insulin Syringes 0.3ml/cc, 31g x 5/16"(8mm); GLUCO-CARE Insulin Syringes 0.3ml/cc, 30G x 5/16"(8mm); GLUCO-CARE Insulin Syringes 1ml/cc, 30G x 5/16"(8mm); GLUCO-CARE Insulin Syringes 1ml/cc, 30G x 1/2"(12.7mm) Safety Hypodermic Needle ONE-CARE Luer-Lock Syringes 1ml; ONE-CARE Luer-Lock Syringes 3ml ONE-CARE Luer-Lock Syringes 5ml; ONE-CARE Luer-Lock Syringes 10ml Irrigating Syringe Enteral syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2019-05-10
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2021-09-23
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2021-07-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-07-13
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2020-08-11
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-09-09
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2019-09-09
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-09-09
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2023-07-25
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2019-04-23

Official Correspondent

Tony Yang

US Agent Details

Kai Li Email: likai323@hotmail.com Phone: (501) 7778490

Related Public Records

Same Entity

Jiangsu Micsafe 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
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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16

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-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014570560. Last updated year: 2026. Please use registration number 3014570560 when referencing this establishment in official correspondence.