Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003310007

FEI Number

3003310007

Entity Name

ANHUI KANGDA MEDICAL PRODUCTS CO., LTD.

City/State/Country

Tianchang City Anhui, CN

Establishment Address

No.88 Zhenxing Road, Yangcun Town, Tianchang City Anhui 239304, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. (Owner Number: 9057034)

Owner / Operator Contact Address

No.88 Zhenxing Road, Yangcun Town, Tianchang City, CN-AH 239304, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K083686

PMA Number

N/A

All Registered Proprietary Names

BAIXIN DENTAL NEEDLE MN Health Inc BAIXIN BLOOD COLLECTION SET Baixin BLUNT FILL NEEDLE BAIXIN SYRINGES AND HYPODERMIC NEEDLES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZM	Needle, Dental	Dental	Class 1	872.4730	2005-05-02
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-06-03
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2024-02-23
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2009-12-21
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-07-16
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2009-12-21

Official Correspondent

Tiantian TAO

US Agent Details

Sam Shi Business: Medwin Inc. Email: MedwinInc@aliyun.com Phone: (626) 2651595

Related Public Records

Same Entity

ANHUI KANGDA MEDICAL PRODUCTS 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
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04

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-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

Similar Registrations

Registration Number	Establishment Name	Location
3005416271	C-K DENTAL IND. CO., LTD.	BUCHEON-SI, GYEONGGI-DO, KR
9612124	AIR WATER REALIZE INC.	IWAKI-SHI Fukushima, JP
3000247873	NIPRO CORPORATION	Settsu Osaka, JP
2416455	COLTENE/WHALEDENT INC.	CUYAHOGA FALLS, OH, US
9611446	NIPRO MEDICAL INDUSTRIES LTD.	TATEBAYASHI-SHI Gunma, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003310007. Last updated year: 2026. Please use registration number 3003310007 when referencing this establishment in official correspondence.