Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010063021

FEI Number

3010063021

Entity Name

TNI MEDICAL AG

City/State/Country

Wurzburg Bavaria, DE

Establishment Address

Nurnberger Str. 74a, Wurzburg Bavaria 97076, DE

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

TNI medical AG (Owner Number: 10051448)

Owner / Operator Contact Address

52 Discovery, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180474

PMA Number

N/A

All Registered Proprietary Names

TNI softFlow 50 Hospital System 10-50L

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2021-01-27

Official Correspondent

Mathew Jimenez

US Agent Details

Mathew Jimenez Business: Masimo Corporation Email: mjimenez@masimo.com Phone: (949) 2977558

Related Public Records

Same Entity

TNI medical AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018900343	Mechatronic GmbH	Hoehn Rhineland-Palatinate, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16

Similar Registrations

Registration Number	Establishment Name	Location
2085602	FISHER & PAYKEL HEALTHCARE, INC.	IRVINE, CA, US
3029906224	Hamilton Medical AG	Domat/Ems Graubunden, CH
3011137372	Teleflex Medical LLC	Morrisville, NC, US
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ
2518422	RESPIRONICS INC.	MURRYSVILLE, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010063021. Last updated year: 2026. Please use registration number 3010063021 when referencing this establishment in official correspondence.