Dongguan Honfield Precision Parts Co., Ltd.
Registered establishment in Zhangmutou, Dongguan, Guangdong, China. 8 device types.
Dongguan Honfield Precision Parts Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Pump, Infusion, Laryngoscope, Rigid and 6 other device types. Its earliest product listing with the FDA dates from 2013.
Registration
| Registered name | DONGGUAN HONFIELD PRECISION PARTS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010564249 |
| FEI number | 3010564249 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
Location
| City | Zhangmutou, Dongguan |
|---|---|
| Province | Guangdong |
| Address | No 1, FuDa 1st Road,, Zhangyang Management District, |
| Postal code | 523630 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Automated Urinalysis System | Class 1 | Minuteful – kidney test | 2022 | 16 |
| Enzymatic Method, Creatinine | Class 2 | Minuteful – kidney test | 2022 | 4 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Class 1 | Minuteful – kidney test | 2022 | 14 |
| Laparoscope, General & Plastic Surgery | Class 2 | Laparoscope, general& plastic surgery system, surgical, computer controlled instrument | 2021 | 46 |
| Laryngoscope, Rigid | Class 1 | DispoLED, Rusch DispoLED, Dispogrip Rusch | 2013 | 44 |
| Pump, Infusion | Class 2 | Accessories for Infusion Pump | 2013 | 5 |
| System, Surgical, Computer Controlled Instrument | Class 2 | Laparoscope, general& plastic surgery system, surgical, computer controlled instrument | 2021 | 4 |
| System, Test, Blood Glucose, Over The Counter | Class 2 | LabStyle Innovations Corp, Dario Health | 2016 | 20 |
Clearances
No clearance names Dongguan Honfield Precision Parts Co., Ltd. as applicant. 3 are held by other companies 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 |
|---|---|---|---|---|
| K172723 | 2018-03-23 | NBW | Traditional | Labstyle Innovation, Ltd. |
| K163159 | 2017-07-19 | NBW | Traditional | Labstyle Innovations, Ltd. |
| K150817 | 2015-12-21 | NBW | Traditional | Labstyle Innovations, Ltd. |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Dong Guan Yi Yi Optical Company Ltd | 2 |
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.