Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012039263

FEI Number

3012039263

Entity Name

Shandong Ande Healthcare Apparatus Co., Ltd.

City/State/Country

Zibo Shandong, CN

Establishment Address

No. 999, Zunxian Road, New & Hi-Tech Zone,, Zibo Shandong 255086, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shandong Ande Healthcare Apparatus Co., Ltd. (Owner Number: 10056160)

Owner / Operator Contact Address

No. 999, Zunxian Road, New & Hi-Tech Zone,, Zibo, CN-SD 255086, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201460

PMA Number

N/A

All Registered Proprietary Names

Disposable IV catheter Auto-disable Syringe for Fixed-dose Immunization Closed System Transfer Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2021-07-26
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-01-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-01-19
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2026-01-19
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2023-10-19

Official Correspondent

Meng Zhang

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

Shandong Ande Healthcare Apparatus 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
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
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-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
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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3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
3015859709	Arrow International, LLC (subsidiary of Teleflex Incorporated)	Wyomissing, PA, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012039263. Last updated year: 2026. Please use registration number 3012039263 when referencing this establishment in official correspondence.