Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034667025

FEI Number

3034667025

Entity Name

YANGZHOU MEDLINE INDUSTRY CO., LTD.

City/State/Country

Yangzhou Jiangsu, CN

Establishment Address

No.99, South Yangzi Road, Yangzhou, 225000 Jiangsu, P.R.China, Yangzhou Jiangsu 225000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Yangzhou Medline Industry Co., Ltd. (Owner Number: 10092036)

Owner / Operator Contact Address

No.99, South Yangzijiang Road, Yangzhou, 225000 Jiangsu, P.R.China, Yangzhou, CN-JS 225000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Oral Syringes, Oral Tip Caps Blood Fill Needle W/O Filter, Blunt Needles W/O Filter Blunt Fill Needle, Filter Needles Surgical Scrub Brush Safety Blood Collection Needle with Holder, Safety Blood Collection Set Safety Blood Collection Needle Blood Collection Set Blood Collection Needle with Holder Safety Blood Collection Set with Holder, Blood Collection Needle Luer Adapter with Holder Blood Collection Set with Holder Blood Transfer Unit, Blood Transfer Adapter, Sample Transfer Unit, Disposable Blood Transfer Unit, Plasma Transfer Unit Irrigation Syringe Respiratory Protective Mask, I9501, II9501 Sterile Disposable Syringe with Safety Needle Sterile Disposable Syringe Sterile Disposable Syringe with Needle Sterile Disposable Safety Needle Sterile Safety Syringe Sterile Disposable Needle Safety Syringe With/Without Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2024-11-27
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2024-11-27
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2025-07-09
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-11-27
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2024-11-27
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2024-11-27
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-11-27
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-11-27
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-11-27
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2024-11-27
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2024-11-27

Official Correspondent

Jianzhong Qi

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Yangzhou Medline Industry 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
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16

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-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
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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3015916830	PACKERMAN SDN. BHD.	Melaka, MY
3010692406	SHANGHAI GUANGSHENG INDUSTRIAL CO.,LTD.	Shanghai, CN
1423537	Cardinal Health 200, LLC	Waukegan, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034667025. Last updated year: 2026. Please use registration number 3034667025 when referencing this establishment in official correspondence.