NEW Prokin International Ltd.
Registered establishment in Zhongshan, Guangdong, China. 5 device types.
NEW Prokin International Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Syringe, Ent, Toothbrush, Manual and 3 other device types. Its earliest product listing with the FDA dates from 2006.
Registration
| Registered name | NEW PROKIN INTERNATIONAL LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005613467 |
| FEI number | 3005613467 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 振杰國際有限公司 |
|---|---|
| Source | Taiwan company register lookup |
Location
| City | Zhongshan |
|---|---|
| Province | Guangdong |
| Address | No.51,Huashixia St.,Shenchong Village, |
| Postal code | 528437 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Continuous Measurement Thermometer | Class 2 | ARC Baby Digital Thermometer | 2017 | 115 |
| Dispenser, Liquid Medication | Class 1 | Medicine Feeder | 2006 | 86 |
| Lift, Patient, Non-Ac-Powered | Class 1 | Lift, Patient, NON-AC-Powered Sling, Lift, Patient, NON-AC-Powered | 2006 | 71 |
| Syringe, Ent | Class 1 | Syringe, ENT | 2006 | 24 |
| Toothbrush, Manual | Class 1 | Toothbrush, Manual | 2006 | 244 |
Clearances
No clearance names NEW Prokin International 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 |
|---|---|---|---|---|
| K851146 | 1985-05-23 | FLL | Traditional | Micro Idea Instrument 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.