Linxens Healthcare (Tianjin) Co., Ltd.
Registered establishment in Jinnan District, Tianjin, China. 7 device types.
Linxens Healthcare (Tianjin) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Electrode, Electrocardiograph, Detector And Alarm, Arrhythmia and 5 other device types. Its earliest product listing with the FDA dates from 2017.
Registration
| Registered name | Linxens Healthcare (Tianjin) Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013791928 |
| FEI number | 3013791928 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Jinnan District |
|---|---|
| Province | Tianjin |
| Address | Room 2, 25 building, LiGang Yuan |
| Postal code | 25 2 101 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Autonomous Extracorporeal Blood Leak Detector/Alarm | Class 2 | Redsense Senser Patch, Redsense Catheter Senser Patch | 2018 | 1 |
| Coronary Artery Disease Risk Indicator From Acoustic Heart Signals | Class 2 | CADScor System | 2022 | 1 |
| Detector And Alarm, Arrhythmia | Class 2 | 2025 | 10 | |
| Electrode, Electrocardiograph | Class 2 | SP2007 Hydrocolloid BG Mini Slide Strip, Universal Patch, SP1003 Acrylic Snapstrip, SP1007 Silicone Snapstrip, SP2003 BodyGuardian Mini Slide Strip, SP2004 BodyGuardian Mini Slide Strip – Acrylic | 2018 | 33 |
| Electrode, Electrocardiograph, Multi-Function | Class 2 | Base SB1002-A, BodyGuardian Mini Bridge SB2002 | 2017 | 6 |
| Stimulator, Nerve, Peripheral, Electric | Class 2 | 2025 | 5 | |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | Class 2 | 2025 | 11 |
From the Company
Published by the company on its own website, not by the FDA.
| Employees | Over 3,500 (global company) |
|---|---|
| Factory area | 2.1 billion RMB (€260 million) investment for Tianjin facility |
| Main products | smart medical components, biosensors, microconnectors, flexible electronics for healthcare |
| Export markets | Global (eight sectors: Government, Payment, Telecom, Healthcare, Leisure & Hospitality, Smart Access, Mobility, IoT) |
| OEM and ODM | Offered |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.