Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018077493

FEI Number

3018077493

Entity Name

FMA MECHATRONIC SOLUTIONS AG

City/State/Country

Schaan, LI

Establishment Address

Im alten Riet 24, Schaan 9494, LI

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FMA Mechatronic Solutions AG (Owner Number: 10080632)

Owner / Operator Contact Address

Im alten Riet 24, Schaan, LI-07 9494, LI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Smart Lung 2000 2 Liter Smart Lung Infant 0.5 Liter Easy Lung Adult 1 Liter Smart Lung Adult 1 Liter FlowAnalyser PF-300 PRO MulitGas Analyzer OR-703 Flow Analyzer PF-301 Flow Analyzer PF-302 CITREX H3 CITREX H5 Flow Analyzer PF-300 CITREX H4

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2021-02-16
BXY	Flowmeter, Calibration, Gas	Anesthesiology	Class 1	868.2350	2021-02-16

Official Correspondent

Erich Trinkler

US Agent Details

Matt Dryden Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

FMA Mechatronic Solutions AG

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018077493. Last updated year: 2026. Please use registration number 3018077493 when referencing this establishment in official correspondence.