FDA Registration
Active
🇨🇳 China
DONGGUAN HONFIELD PRECISION PARTS CO., LTD
Reg #: 3010564249
·
FEI: 3010564249
·
Expires 2026
Products
8
Proprietary Names
8
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- DONGGUAN HONFIELD PRECISION PARTS CO., LTD
- Registration Number
- 3010564249
- FEI Number
- 3010564249
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No 1, FuDa 1st Road,, Zhangyang Management District,, Zhangmutou, Dongguan, GUANGDONG
- City
- Zhangmutou, Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K163159
Owner / Operator
- Firm Name
- Dongguan Honfield Precision Parts Co., Ltd
- Operator Number
- 10045598
- Address
- No 1, FuDa 1st Road,, Zhangyang Management District,
- City
- Zhangmutou, Dongguan
- State
- Guangdong
- Postal Code
- 523630
- Country
- CN
- Correspondent
- Paul Miu
US Agent
- Business Name
- LLINS TECHNOLOGY INC
- Contact Name
- James Wang
- Address
- 1312 17th Street,, Unit #2199, Denver, CO 80202 US
- City
- Denver
- State
- CO
- ZIP
- 80202
- Country
- US
- [email protected]
- Phone
- 720 2171916
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2013-12-15 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2021-03-03 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2021-03-03 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2018-12-19 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2013-12-05 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2022-11-09 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2022-11-09 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2022-11-09 |
Proprietary Names
Rusch DispoLED
DispoLED
DISPOGRIP RUSCH
Laparoscope, general& plastic surgery system, surgical, computer controlled instrument
Dario Health
LabStyle Innovations Corp
Accessories for Infusion Pump
Minuteful - kidney test
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device