Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012606445

FEI Number

3012606445

Entity Name

Linxens Sweden AB

City/State/Country

Angelholm Skane, SE

Establishment Address

Brandsvigsgatan 11A, Angelholm Skane 26273, SE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Linxens Sweden AB (Owner Number: 10051513)

Owner / Operator Contact Address

Brandsvigsgatan 11A, Angelholm, SE-M 26273, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BodyGuardian Mini Bridge SB2002

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2025-04-15
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2025-04-15
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2023-12-12
MLN	Electrode, Electrocardiograph, Multi-Function	Cardiovascular	Class 2	870.2360	2016-03-29

Official Correspondent

Carina Backstrom Hassel

US Agent Details

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

Related Public Records

Same Entity

Linxens Sweden AB

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
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
K151681	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Patient Monitor	2015-07-17

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
3033118181	CHERO TECHNOLOGY CO., LTD.	Jiaxing Zhejiang, CN
3026960443	Cicor Medtec Bucharest	Bucharest Bucuresti, RO
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB
3012302888	QUIPMENT INC.	Kennesaw, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012606445. Last updated year: 2026. Please use registration number 3012606445 when referencing this establishment in official correspondence.