FDA Registration
Active
🇨🇳 China
ProteXsure Safety Capsule System
Reg #: 3012944064
·
FEI: 3012944064
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN HYS MEDICAL CO., LTD.
- Registration Number
- 3012944064
- FEI Number
- 3012944064
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 3, Huayisheng Industrial Park, Fenghuang Village, Fuyong Town, Bao'an District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K152597
Owner / Operator
- Firm Name
- Shenzhen HuaYi Safety Medical Technology co., Ltd.
- Operator Number
- 10052396
- Address
- Hua Yi Sheng Ind. Park, #4 Industrial Zo, Fenhuang Village
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518103
- Country
- CN
US Agent
- Business Name
- JB Medical Development, LLC
- Contact Name
- Howard Jeck
- Address
- 3650 Coral Ridge Drive - Unit 107
- City
- Coral Springs
- State
- FL
- ZIP
- 33065
- Country
- US
- [email protected]
- Phone
- 877 6036333
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2016-07-22 |
Proprietary Names
ProteXsure Safety Capsule System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)