Data / Medical devices / China / Dongguan Honfield Precision Parts Co., Ltd
Dongguan Honfield Precision Parts Co., Ltd: FDA-registered device maker in Zhangmutou, Dongguan Guangdong, China, 3 510(k) clearances
Dongguan Honfield Precision Parts Co., Ltd is registered with the FDA (registration 3010564249) in Zhangmutou, Dongguan Guangdong, China. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 23, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010564249
- Address
- No 1, FuDa 1st Road,, Zhangyang Management District, Zhangmutou, Dongguan, GUANGDONG, Zhangmutou, Dongguan Guangdong, China, 523630
- Owner or operator
- Dongguan Honfield Precision Parts Co., Ltd (10045598)
- Roles
- Contract manufacturer, Exporter to the US, Repackager or relabeler
- First device listed
- December 5, 2013
- Registered through
- 2026
- Brand names listed
- Accessories for Infusion Pump, DISPOGRIP RUSCH, Dario Health, DispoLED, LabStyle Innovations Corp, Laparoscope, general& plastic surgery system, surgical, computer controlled instrument, Minuteful - kidney test, Rusch DispoLED
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Urinalysis System | KQO | 1 | Contract manufacturer | accessdata.fda.gov |
| Enzymatic Method, Creatinine | JFY | 2 | Contract manufacturer | accessdata.fda.gov |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | 1 | Contract manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Contract manufacturer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Surgical, Computer Controlled Instrument | NAY | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| March 23, 2018 | K172723 | Dario LC Blood Glucose Monitoring System | NBW | Substantially Equivalent | Labstyle Innovation, Ltd. | accessdata.fda.gov |
| July 19, 2017 | K163159 | Dario Blood Glucose Monitoring System | NBW | Substantially Equivalent | Labstyle Innovations, Ltd. | accessdata.fda.gov |
| December 21, 2015 | K150817 | Dario Blood Glucose Monitoring System | NBW | Substantially Equivalent | Labstyle Innovations, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Infusion
- All makers of Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- All makers of Automated Urinalysis System
- All makers of Enzymatic Method, Creatinine
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Laryngoscope, Rigid
Updated March 23, 2018. 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.