Data / Medical devices / China / New Prokin International Ltd.
New Prokin International Ltd.: FDA-registered device maker in Zhongshan City Guangdong, China, 1 510(k) clearance
New Prokin International Ltd. is registered with the FDA (registration 3005613467) in Zhongshan City Guangdong, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 23, 1985. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005613467
- Address
- No.51,Huashixia St.,Shenchong Village, Torch Development Zone, Zhongshan City Guangdong, China, 528437
- Owner or operator
- NEW PROKIN INTERNATIONAL LTD. (9083480)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- February 27, 2006
- Registered through
- 2026
- Brand names listed
- ARC Baby Digital Thermometer, LIFT, PATIENT, NON-AC-POWERED, LIFT, PATIENT, NON-AC-POWERED SLING, MEDICINE FEEDER, SYRINGE, ENT, TOOTHBRUSH, MANUAL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Lift, Patient, Non-Ac-Powered | FSA | 1 | Contract manufacturer | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| May 23, 1985 | K851146 | DIGITAL THERMOMETER | FLL | Substantially Equivalent | Micro Idea Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Dispenser, Liquid Medication
- All makers of Syringe, Ent
- All makers of Lift, Patient, Non-Ac-Powered
- All makers of Toothbrush, Manual
Updated May 23, 1985. 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.