Jiangmen NEW ERA External Drug USE Co., Ltd.
Registered establishment in Jiangmen, Guangdong, China. 1 device type.
Jiangmen NEW ERA External Drug USE Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Indicator, Physical/Chemical Sterilization Process. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | JIANGMEN NEW ERA EXTERNAL DRUG USE CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3035856230 |
| FEI number | 3035856230 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 江门市新时代外用制剂有限公司 |
|---|---|
| Source | provincial manufacturer licence lists |
Location
| City | Jiangmen |
|---|---|
| Province | Guangdong |
| Address | No.8 Beiyuan Rd, Jianghai District |
| Postal code | 529000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | Class 2 | Autoclave Indicator Tape; EO Indicator Tape | 2025 | 19 |
Clearances
No clearance names Jiangmen NEW ERA External Drug USE 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 |
|---|---|---|---|---|
| K241036 | 2024-12-17 | JOJ | Traditional | Jiangmen New Era External Use Drug Co., Ltd. |
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.