Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006948863

FEI Number

3006948863

Entity Name

REDSENSE MEDICAL AB

City/State/Country

Halmstad Halland, SE

Establishment Address

Storgatan 36, Halmstad Halland 302 43, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Redsense Medical AB (Owner Number: 10025092)

Owner / Operator Contact Address

Storgatan 36, Halmstad, SE-N 302 43, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K103242

PMA Number

N/A

All Registered Proprietary Names

Redsense alarm system Redsense Medical Redsense alarm unit and sensor

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	2013-12-31
ODX	Autonomous Extracorporeal Blood Leak Detector/Alarm	Gastroenterology, Urology	Class 2	876.5820	2008-03-13
ODX	Autonomous Extracorporeal Blood Leak Detector/Alarm	Gastroenterology, Urology	Class 2	876.5820	2011-12-01

Official Correspondent

Ann-Marie Eriksson

US Agent Details

Jane Hurst Business: Redsense Medical Inc Email: jane.hurst@redsensemedical.com Phone: (937) 2141771

Related Public Records

Same Entity

Redsense Medical AB

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006948863. Last updated year: 2026. Please use registration number 3006948863 when referencing this establishment in official correspondence.