Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003591759

FEI Number

3003591759

Entity Name

GONOTEC GESELLSCHAFT FUER MESS-UND REGELTECHNIK MBH

City/State/Country

BERLIN, DE

Establishment Address

Reuchlinstr. 10-11, BERLIN D-10553, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GONOTEC Gesellschaft fuer Mess- und Regeltechnik mbH (Owner Number: 9048267)

Owner / Operator Contact Address

Reuchlinstr. 10-11, --, BERLIN, DE-BE 10553, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GONOTEC Calibration Standard 500mOsmol/kg NaCl/H2O GONOTEC Calibration Standard 300mOsmol/kg NaCl/H2O GONOTEC Calibration Standard 100mOsmol/kg NaCl/H2O GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O GONOTEC Calibration Standard 2000mOsmol/kg NaCl/H2O GONOTEC Reference Solution OSMOREF® 290mOsmol/kg NaCl/H2O FreezePoint® Freezing Point Osmometer, Model 6000S FreezePoint® Freezing Point Osmometer, Model 6000P FreezePoint® Freezing Point Osmometer, Model 6000 FreezePoint® Freezing Point Osmometer, Model 6000SP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2008-02-04
JJM	Osmometer For Clinical Use	Clinical Chemistry	Class 1	862.2730	2001-10-30

Official Correspondent

Florian Bornschein

US Agent Details

Bryce McEuen Email: bryce.mceuen@elitechgroup.com Phone: (435) 7526011

Related Public Records

Same Entity

GONOTEC Gesellschaft fuer Mess- und Regeltechnik mbH

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
Z-0033-2022	Sentinel CH SpA Via Robert Koch	2	Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.

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1181121	Fisher Diagnostics	MIDDLETOWN, VA, US
2250051	ORTHO-CLINICAL DIAGNOSTICS, INC.	RARITAN, NJ, US
9612316	TOSOH AIA, INC.	TOYAMA, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003591759. Last updated year: 2026. Please use registration number 3003591759 when referencing this establishment in official correspondence.