FDA Registration
Active
🇨🇳 China
Monopolar single-use HF cable
Reg #: 3013509672
·
FEI: 3013509672
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DONGGUAN HUGECONN INDUSTRIAL LIMITED
- Registration Number
- 3013509672
- FEI Number
- 3013509672
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Block 37, Arising Sun Industrial City, Lincun, Tang Sha Town
- City
- Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K160053
Owner / Operator
- Firm Name
- Dongguan Hugeconn Industrial Limited
- Operator Number
- 10054222
- Address
- Block 37, Arising Sun Industrial City, Lincun, Tang Sha Town
- City
- Dongguan
- State
- Guangdong
- Postal Code
- 523711
- Country
- CN
- Correspondent
- Floys Fung
US Agent
- Business Name
- Gyrus ACMI, Inc.
- Contact Name
- Todd Brill
- Address
- 800 West Park Drive, --
- City
- Westborough
- State
- MA
- ZIP
- 01581
- Country
- US
- [email protected]
- Phone
- 508 2077661
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2017-02-24 |
Proprietary Names
Monopolar single-use HF cable
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)