Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010837197

FEI Number

3010837197

Entity Name

FISCHER ANALYSEN INSTRUMENTE GMBH

City/State/Country

Leipzig Saxony, DE

Establishment Address

Brahestr. 25-27, Leipzig Saxony 04347, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Fischer ANalysen Instrumente GmbH (Owner Number: 10062455)

Owner / Operator Contact Address

Brahestr. 25-27, Leipzig, DE-SN 04347, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P170022

All Registered Proprietary Names

PyloPlus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OZA	Test, Urea Adult And Pediatric (Breath),	Microbiology	Class 3	866.3110	2020-03-05

Official Correspondent

Martin Schaich

US Agent Details

Philip Ross Business: Gulf Coast Scientific, Inc. / ARJ Medical, Inc. Email: PRoss@gulfcoastscientific.com Phone: (813) 8551557

Related Public Records

Same Entity

Fischer ANalysen Instrumente GmbH

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3004577174	ARJ MEDICAL, LLC. / Gulf Coast Scientific, LLC.	Tampa, FL, US
3031365458	WOMED SAS	Montpellier Herault, FR
3009999323	STORE-ALL LOGISTICS LTD	Slieverue Kilkenny, IE
3008478369	FERROSAN MEDICAL DEVICES A/S	Soeborg Hovedstaden, DK
3028907862	XVIVO PERFUSION, INC.	Aurora, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010837197. Last updated year: 2026. Please use registration number 3010837197 when referencing this establishment in official correspondence.