Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008449424

FEI Number

3008449424

Entity Name

GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

No.102, Kaiyuan Avenue, Science City, Guangzhou Economic & Technological Development District, Guangzhou Guangdong 510530, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangzhou Improve Medical Instruments Co., Ltd. (Owner Number: 10038705)

Owner / Operator Contact Address

No.102, Kaiyuan Avenue, Science City, Guangzhou Economic & Technological Development District, PEOPLE'S REPUBLIC OF CHINA, Guangzhou, CN-GD 510530, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K093910

PMA Number

N/A

All Registered Proprietary Names

IMPROVACUTER® Multi Sample Needle IMPROSAFE® Multi Sample Needle (Flashback) IMPROVACUTER® Blood Collection Set Pre-attached Holder IMPROSAFE® Blood Collection Set with Pre-attached Holder IMPROSAFE® Multi Sample Needle IMPROSAFE® Blood Collection Set IMPROVACUTER® Blood Collection Set Improve Blood Collection Set and Improsafe Blood Collection Set TOURNIQUET, NONPNEUMATIC Urinalysis No Additive Tube No Additive Tube Urinalysis Preservative Tube No Additive (Z) Tube IMPROVACUTER® Gel & Clot Activator Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-06-14
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2013-11-18
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2025-01-16
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2020-04-14
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2011-11-07

Official Correspondent

No official correspondent registered.

US Agent Details

Chang Che Business: IMPROVE MEDICAL USA, INC. Email: info@improvemedicalusa.com Phone: (760) 2018878

Related Public Records

Same Entity

Guangzhou Improve Medical Instruments 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
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

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-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.

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3010621964	ATLAS MEDICAL PRODUCTS LLC	Hialeah, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008449424. Last updated year: 2026. Please use registration number 3008449424 when referencing this establishment in official correspondence.