FDA Registration
Active
🇨🇳 China
Linxens Healthcare (Tianjin) Co., Ltd
Reg #: 3013791928
·
FEI: 3013791928
·
Expires 2026
Products
7
Proprietary Names
11
Establishment Types
1
Classifications
7
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Registration Details
- Registration Name
- Linxens Healthcare (Tianjin) Co., Ltd
- Registration Number
- 3013791928
- FEI Number
- 3013791928
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 2, 25 building, LiGang Yuan, ShuangGang industrial Yuan
- City
- JinNan District Tianjin
- Country
- CN
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
- QRx Partners
- Contact Name
- Mark Swanson
- Address
- 16904 77th Street SE
- City
- Becker
- State
- MN
- ZIP
- 55308
- Country
- US
- [email protected]
- Phone
- 833 7797278
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 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2018-02-06 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2025-04-08 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2025-04-08 |
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2025-02-12 |
| Electrode, Electrocardiograph, Multi-Function | MLN | Class 2 | Cardiovascular | No | 2017-08-09 |
| Coronary Artery Disease Risk Indicator From Acoustic Heart Signals | QMW | Class 2 | Cardiovascular | No | 2022-03-29 |
Proprietary Names
Redsense Catheter Senser Patch
Redsense Senser Patch
SP1007 Silicone Snapstrip
SP2004 BodyGuardian Mini Slide Strip - Acrylic
Universal Patch
SP2007 Hydrocolloid BG Mini Slide Strip
SP2003 BodyGuardian Mini Slide Strip
SP1003 Acrylic Snapstrip
Base SB1002-A
BodyGuardian Mini Bridge SB2002
CADScor System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)