Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019771924

FEI Number

3019771924

Entity Name

INOSYSTEMS

City/State/Country

ANTONY Hauts-de-Seine, FR

Establishment Address

7 RUE GEORGES BESSE, ANTONY Hauts-de-Seine 92160, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

INOSYSTEMS (Owner Number: 10088379)

Owner / Operator Contact Address

7 RUE GEORGES BESSE, ANTONY, FR-92 92160, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ulspira TS Nitric Oxide Therapy System Ulspira TS Nitric Oxide Therapy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2023-07-21
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2025-02-03
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2025-02-03
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2025-02-03
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2025-02-03
MRO	Apparatus, Nitric Oxide, Backup Delivery	Anesthesiology	Class 2	868.5165	2025-02-03

Official Correspondent

SOPHIE DUBOUDIN

US Agent Details

Michael H.Hinckle Business: K&L Gates LLP Email: michael.hinckle@klgates.com Phone: (919) 4661115

Related Public Records

Same Entity

INOSYSTEMS

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
K072469	Digiflo, Inc.	DIGIFLO CONCENTRATOR ANALYZER	2008-01-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2026	NOXBOX LTD	2	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Z-0029-2026	NOXBOX LTD	2	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

Similar Registrations

Registration Number	Establishment Name	Location
3004531588	Mallinckrodt Manufacturing LLC	MADISON, WI, US
3012796317	NOXBOX LIMITED	Sittingbourne Kent, GB
3011193444	C2C DEVELOPMENT, LLC	Melbourne, FL, US
2133810	MINNETRONIX, INC.	Saint Paul, MN, US
2518435	Airgas Therapeutics LLC	PLUMSTEADVILLE, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019771924. Last updated year: 2026. Please use registration number 3019771924 when referencing this establishment in official correspondence.