FDA Registration
Active
🇨🇳 China
Surgical Gown
Reg #: 3033848619
·
FEI: 3033848619
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Hilo Healthcare China Co.,ltd
- Registration Number
- 3033848619
- FEI Number
- 3033848619
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- YuAn Industrial Park
- City
- Lu'An Anhui
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K093835
Owner / Operator
- Firm Name
- Hilo Industries LLC
- Operator Number
- 10073187
- Address
- 7035 E Pecos Rd, STE 1001 Bldg 1
- City
- Mesa
- State
- AZ
- Postal Code
- 85212
- Country
- US
- Correspondent
- Daniel Marquardt
US Agent
- Business Name
- HILO INDUSTRIES LLC
- Contact Name
- Daniel Marquardt
- Address
- 10432 Balls Ford Rd Ste 300
- City
- Manassas
- State
- VA
- ZIP
- 20109
- Country
- US
- [email protected]
- Phone
- 703 3484613
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2021-11-11 |
Proprietary Names
Surgical Gown
Standard Surgical Gown
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)