Guangzhou Improve Medical Instruments Co., Ltd.
Manufacturer and brand owner in Guangzhou, Guangdong, China. 6 device types, 14 products catalogued, 2 clearances.
Guangzhou Improve Medical Instruments Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Tourniquet, Nonpneumatic, Container, Specimen, Sterile and 4 other device types. 14 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008449424 |
| FEI number | 3008449424 |
| DUNS | 530148444 |
| Establishment type | Contract manufacturer, Specification developer, Manufacturer |
Chinese Registration
| Chinese legal name | 广州阳普医疗器械有限公司 |
|---|---|
| Unified social credit code | 91440101MA9XQ1U5XH |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | No.102, Kaiyuan Avenue, Science City, Guangzhou Economic & Technological Development District |
| Postal code | 510530 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Container, Specimen, Non-Sterile | Class 1 | Urine Collection Container | 2025 | 115 |
| Container, Specimen, Sterile | Class 1 | No Additive Tube, No Additive (Z) Tube, Urinalysis Preservative Tube, Urinalysis No Additive Tube | 2020 | 79 |
| Needle, Hypodermic, Single Lumen | Class 2 | IMPROSAFE® Multi Sample Needle (Flashback), IMPROVACUTER® Blood Collection Set, IMPROSAFE® Blood Collection Set with Pre-attached Holder, IMPROVACUTER® Multi Sample Needle, IMPROSAFE® Blood Collection Set, IMPROSAFE® Multi Sample Needle and 1 more | 2016 | 71 |
| System, Blood Collection, Vacuum-Assisted, Manual | Class 1 | Needle Holder | 2022 | 31 |
| Tourniquet, Nonpneumatic | Class 1 | Tourniquet, Nonpneumatic | 2025 | 124 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | IMPROVACUTER® Gel & Clot Activator Tube, Improve Blood Collection Set and Improsafe Blood Collection Set | 2011 | 23 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Improsafe® Blood Collection Set | FMI | 30 |
| Improsafe® Blood Collection Set with Pre-Attached Holder | FMI | 29 |
| Improvacuter® Blood Collection Set | FMI | 27 |
| Improvacuter® Blood Collection Set with Pre-Attached Holder | FMI | 24 |
| Improvacuter® Gel & Clot Activator Tube | JKA | 21 |
| Improsafe® Multi Sample Needle | FMI | 16 |
| Improsafe® Multi Sample Needle (Flashback) | FMI | 12 |
| Improvacuter® Multi Sample Needle | FMI | 8 |
| Needle Holder | KST | 2 |
| Urine Collection Tube | FMH | 2 |
| Urinalysis Preservative Tube | FMH | 2 |
| Mprosafe® Multi-sample Needle | FMI | 2 |
| Improvacuter® Tourniquet | GAX | 2 |
| Improvacuter® Disposable Tourniquet | GAX | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K153388 | 2016-06-07 | FMI | Traditional | This company |
| K093910 | 2010-07-12 | JKA | Traditional | This company |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2017-09-22 | Class II | Nonconforming Material/Component | Complain due to the hub needle came out when the nurse draw the blood and removed the tube. | 550,000 |
| 2017-09-22 | Class II | Under Investigation by firm | Leaks complaints. | 200,000 |
| 2016-10-19 | Class II | Nonconforming Material/Component | Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip. | 700,000 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1996 |
|---|---|
| Main products | Specimen management systems, Blood collection solutions, Laboratory diagnostic platforms |
| Certifications | Guangdong Grade A medical device, US FDA approval for viral transport media |
| Export markets | United States, multiple countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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