FDA Registration
Active
🇨🇳 China
Redsense Catheter Senser Patch
Reg #: 3013791928
·
FEI: 3013791928
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Linxens Healthcare (Tianjin) Co., Ltd
- Registration Number
- 3013791928
- FEI Number
- 3013791928
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 2, 25 building, LiGang Yuan, ShuangGang industrial Yuan
- City
- JinNan District Tianjin
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K130554
Owner / Operator
- Firm Name
- Linxens Healthcare (Tianjin) Co., Ltd
- Operator Number
- 10055548
- Address
- Room 2, 25 building, LiGang Yuan, ShuangGang industrial Yuan
- City
- JinNan District
- State
- Tianjin
- Postal Code
- 25 2 101
- Country
- CN
- Correspondent
- William HUANG
US Agent
- Business Name
- Braemar Manufacturing LLC
- Contact Name
- Tahnee Mehta
- Address
- 1285 Corporate Center Drive, Suite 150
- City
- Eagan
- State
- MN
- ZIP
- 55121
- Country
- US
- [email protected]
- Phone
- 610 3018921 ext. 1
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Autonomous Extracorporeal Blood Leak Detector/Alarm | ODX | Class 2 | Gastroenterology, Urology | No | 2018-12-18 |
Proprietary Names
Redsense Catheter Senser Patch
Redsense Senser Patch
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)