Data / Medical devices / China / Zhangzhou Aoxi Plastic Co., Ltd.
Zhangzhou Aoxi Plastic Co., Ltd.: FDA-registered device maker in ZHANGZHOU Fujian, China, 1 510(k) clearance
Zhangzhou Aoxi Plastic Co., Ltd. is registered with the FDA (registration 3004127962) in ZHANGZHOU Fujian, China. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 17, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004127962
- Address
- No 6 Yonghui Road YANXI TOWN, CHANGTAI DISTRICT, ZHANGZHOU Fujian, China, 363900
- Owner or operator
- ZHANGZHOU AOXI PLASTIC CO., LTD. (9058002)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- August 12, 2003
- Registered through
- 2026
- Brand names listed
- ABSORBENT TIPPED, CURETTE, FOR INDWELLING CATHETER GASTROENTE, NON-STERILE#GENERAL HOSPITAL, ROLOGY-UROLO, SAF-T-CUBE, SPECIMEN, STERILE#GENERAL HOSPITAL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amniotome | HGE | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Curette, Uterine | HCY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| April 17, 2006 | K052843 | BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE | FMI | Substantially Equivalent | Busse Hospital Disposables, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Urinary Drainage Collection Kit, For Indwelling Catheter
- All makers of Amniotome
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Curette, Uterine
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Container, Specimen, Sterile
Updated April 17, 2006. 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.