Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003630525

FEI Number

3003630525

Entity Name

MEDISOFT S.A.

City/State/Country

DINANT Namur, BE

Establishment Address

Rue du Clairon 5, DINANT Namur 5503, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDISOFT S.A. (Owner Number: 9049133)

Owner / Operator Contact Address

Rue du Clairon 5, Sorinnes, BE-WNA 5503, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K042595

PMA Number

N/A

All Registered Proprietary Names

Fenom Pro TransAir2 Body Box SpiroAir

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	Class 2	862.3080	2025-08-20
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2008-04-15
JEH	Plethysmograph, Volume	Anesthesiology	Class 2	868.1760	2008-04-15
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2008-04-15

Official Correspondent

Eric Dion

US Agent Details

James M. McGurran Business: MGC Diagnostic Email: jmcgurran@mgcdiagnostics.com Phone: (651) 7663495

Related Public Records

Same Entity

MEDISOFT S.A.

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
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09

Similar Registrations

Registration Number	Establishment Name	Location
3001082393	BOSCH HEALTHCARE SOLUTIONS GMBH	Waiblingen Baden-Wurttemberg, DE
3008662397	NIOX AB	Uppsala, SE
3003366417	LRE MEDICAL GMBH	NOERDLINGEN Bavaria, DE
3004167884	PHC Corporation	MIMA Tokushima, JP
3012926714	NIOX Group Plc	Oxford Oxfordshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003630525. Last updated year: 2026. Please use registration number 3003630525 when referencing this establishment in official correspondence.