M DIALYSIS AB

FDA Device Registration & Listing · Stockholm, SE · Registration 3003733874

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003733874
FEI Number
3003733874
Entity Name
M DIALYSIS AB
City/State/Country
Stockholm, SE
Establishment Address
Hammarby Fabriksvag 43, Stockholm SE-120 30, SE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
M Dialysis AB (Owner Number: 9010619)
Owner / Operator Contact Address
Hammarby Fabriksvag 43, --, Stockholm, SE-NOTA 120 30, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K071984
PMA Number
N/A

All Registered Proprietary Names

Cerebral Tissue Monitoring System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2011-02-22

Official Correspondent

No official correspondent registered.

US Agent Details

Kelly Nashawaty Business: M Dialysis Inc. Email: kelly.nashawaty@mdialysis.com Phone: (978) 7103296

Related Public Records

Same Entity

M Dialysis 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
K020558 Integra Neurosciences LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE 2002-03-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003733874. Last updated year: 2026. Please use registration number 3003733874 when referencing this establishment in official correspondence.
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