Zhangzhou Aoxi Plastic Co., Ltd.
Registered establishment in Zhangzhou, Fujian, China. 7 device types.
Zhangzhou Aoxi Plastic Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Amniotome, Curette, Uterine and 5 other device types. Its earliest product listing with the FDA dates from 2003.
Registration
| Registered name | ZHANGZHOU AOXI PLASTIC CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004127962 |
| FEI number | 3004127962 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 漳州澳溪塑料制品有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Zhangzhou |
|---|---|
| Province | Fujian |
| Address | No 6 Yonghui Road |
| Postal code | 363900 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Amniotome | Class 1 | amniotome | 2007 | 5 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | NON-Sterile#general Hospital, Absorbent Tipped | 2003 | 186 |
| Container, Specimen, Sterile | Class 1 | Specimen, Sterile#general Hospital | 2003 | 79 |
| Curette, Uterine | Class 1 | Uterine Obstetrics AND Gynecology, Curette | 2005 | 8 |
| Needle, Hypodermic, Single Lumen | Class 2 | SAF-T-Cube | 2006 | 71 |
| Tray, Surgical, Instrument | Class 1 | tray, surgical instrument | 2005 | 105 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | Class 2 | FOR Indwelling Catheter Gastroente, Urinary Drainage Collection, Rology-Urolo | 2005 | 11 |
Clearances
No clearance names Zhangzhou Aoxi Plastic Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K052843 | 2006-04-17 | FMI | Traditional | Busse Hospital Disposables |
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.
The manufacturer named here can complete this record.