Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005670221

FEI Number

3005670221

Entity Name

JIANGSU CAINA MEDICAL CO., LTD

City/State/Country

Jiangyin Jiangsu, CN

Establishment Address

No.23, Huanxi Road, Zhutang Town, Jiangyin Jiangsu 214415, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Caina Medical Co., Ltd (Owner Number: 10038768)

Owner / Operator Contact Address

No.23, Huanxi Road, Zhutang Town, Jiangyin, CN-JS 214415, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220184

PMA Number

N/A

All Registered Proprietary Names

Insulin Safety Syringe BLUNT CANNULA LOR Syringe Pen Needle ENFit Oral / Enteral Syringe SYRINGE CURVED Retractable Safety Syringe Blood Collection Tube Holder Shrouded needle Standard Tube Holder NRFit Syinge Sure-snap safety needle Syringe ENFit Syringe,ENFit Syringe cap Disposable Sterile Needle Standard Hypodermic Needle Safety Blood Collection Needle with/without Holder Blood Collection Needle with/without Holder Luer Access Device-holder with Preattached Multiple Sample Adapter PAL Infiltration Device Luer Lock Syringe Without Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2023-12-15
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2020-06-30
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2021-03-26
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-11-16
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2019-09-25
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2018-11-05
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2019-12-04
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2021-11-02
QEH	Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact	General Hospital	Class 2	880.5860	2018-12-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-07-25
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2023-07-25
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-07-25
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2018-11-05
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2021-03-26
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2022-02-25
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-12-19
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2020-07-02
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2022-11-13
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2020-10-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-10-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-09-14

Official Correspondent

Jun Lu

US Agent Details

Bryan Wong Business: PUREVISION AL, INC Email: Info@Pureglobal.com Phone: (888) 7681688

Related Public Records

Same Entity

Jiangsu Caina Medical 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
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K203410	Shantou Wealy Medical Instrument Co.,Ltd	ENFit Disposable Enteral Syringe	2021-06-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-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

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3029328631	PEGASUS IMPORTS	Houston, TX, US
3012116434	ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.	Taihu Anhui, CN
3015528193	Almac Pharma Services (Ireland) Limited	Dundalk Louth, IE
3008719222	ZHEJIANG LONGDE PHARMACEUTICAL Co., Ltd	HANGZHOU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005670221. Last updated year: 2026. Please use registration number 3005670221 when referencing this establishment in official correspondence.