Data / Medical devices / China / Guangzhou Improve Medical Instruments Co., Ltd.
Guangzhou Improve Medical Instruments Co., Ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 2 510(k) clearances
Guangzhou Improve Medical Instruments Co., Ltd. is registered with the FDA (registration 3008449424) in Guangzhou Guangdong, China. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 7, 2016. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008449424
- Address
- No.102, Kaiyuan Avenue, Science City, Guangzhou Economic & Technological Development District, Guangzhou Guangdong, China, 510530
- Owner or operator
- Guangzhou Improve Medical Instruments Co., Ltd. (10038705)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- November 7, 2011
- Registered through
- 2026
- Brand names listed
- IMPROSAFE® Blood Collection Set, IMPROSAFE® Blood Collection Set with Pre-attached Holder, IMPROSAFE® Multi Sample Needle, IMPROSAFE® Multi Sample Needle (Flashback), IMPROVACUTER® Blood Collection Set, IMPROVACUTER® Blood Collection Set Pre-attached Holder, IMPROVACUTER® Gel & Clot Activator Tube, IMPROVACUTER® Multi Sample Needle and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen, Non-Sterile | NNI | 1 | Specification developer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | Manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Specification developer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 7, 2016 | K153388 | IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle | FMI | Substantially Equivalent | Guangzhou Improve Medical Instruments Co., Ltd. | accessdata.fda.gov |
| July 12, 2010 | K093910 | IMPROVACUTER GEL & CLOT ACTIVATOR TUBE | JKA | Substantially Equivalent | Guangzhou Improve Medical Instruments Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 22, 2017 | 80547 | Class II | Ongoing | Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle | Complain due to the hub needle came out when the nurse draw the blood and removed the tube. | accessdata.fda.gov |
| September 22, 2017 | 80524 | Class II | Ongoing | Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO | Leaks complaints. | accessdata.fda.gov |
| October 19, 2016 | 80519 | Class II | Ongoing | Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consis | Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip. | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Specimen, Non-Sterile
- All makers of Container, Specimen, Sterile
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of System, Blood Collection, Vacuum-Assisted, Manual
- All makers of Tourniquet, Nonpneumatic
- All makers of Needle, Hypodermic, Single Lumen
Updated June 7, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.