Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013791928

FEI Number

3013791928

Entity Name

Linxens Healthcare (Tianjin) Co., Ltd

City/State/Country

JinNan District Tianjin, CN

Establishment Address

Room 2, 25 building, LiGang Yuan, ShuangGang industrial Yuan, JinNan District Tianjin 25 2 101, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Linxens Healthcare (Tianjin) Co., Ltd (Owner Number: 10055548)

Owner / Operator Contact Address

Room 2, 25 building, LiGang Yuan, ShuangGang industrial Yuan, JinNan District, CN-TJ 25 2 101, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODX	Autonomous Extracorporeal Blood Leak Detector/Alarm	Gastroenterology, Urology	Class 2	876.5820	2018-12-18
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2018-02-06
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2025-04-08
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2025-04-08
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2025-02-12

Official Correspondent

William HUANG

US Agent Details

Mark Swanson Business: QRx Partners Email: mark.swanson@qrxpartners.com Phone: (833) 7797278

Related Public Records

Same Entity

Linxens Healthcare (Tianjin) Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
K131913	Philips Medizin Systeme Boeblingen GmbH	INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC	2013-11-26
K891148	Del Mar Avionics	MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM	1989-05-11
K914092	Nihon Kohden America, Inc.	BSM-2100A CONFIGURED PATIENT MONITOR	1992-05-28
K153473	Braemar Manufacturing, LLC	Braemar Telemetry Patch System	2016-07-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2025	Philips North America	2	IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Z-0030-05	General Electric Medical Systems Information Technology	2	GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6
Z-0034-2011	Philips Medical Systems North America Co. Phillips	2	The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.
Z-0035-2025	Philips North America	2	Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

Similar Registrations

Registration Number	Establishment Name	Location
3006948863	REDSENSE MEDICAL AB	Halmstad Halland, SE
3015335038	ERIKA DE REYNOSA, S.A. DE C.V.	CD, REYNOSA Tamaulipas, MX
1225714	Fresenius Medical Care Renal Therapies Group, LLC	Waltham, MA, US
8030665	ERIKA DE REYNOSA, S.A. DE C.V.	CD, REYNOSA Tamaulipas, MX
3004111573	Sterigenics US LLC	Grand Prairie, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013791928. Last updated year: 2026. Please use registration number 3013791928 when referencing this establishment in official correspondence.