Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018900343

FEI Number

3018900343

Entity Name

Mechatronic GmbH

City/State/Country

Hoehn Rhineland-Palatinate, DE

Establishment Address

Am Gewerbepark 2, Hoehn Rhineland-Palatinate 56462, DE

Establishment Type(s)

Repack or Relabel Medical Device,Remanufacture Medical Device

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

No proprietary names listed under this establishment.

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
3010063021	TNI MEDICAL AG	Wurzburg Bavaria, 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
3010063021	TNI MEDICAL AG	Wurzburg Bavaria, DE
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

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018900343. Last updated year: 2026. Please use registration number 3018900343 when referencing this establishment in official correspondence.