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GONOTEC Gesellschaft für Meß- und Regeltechnik mbH

Active in EUDAMED

Germanyfrom SRN EUDAMED FDA SRN DE-MF-000006548

Devices
12
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment

Catalogue12

Company details

EUDAMED SRN
DE-MF-000006548
EU VAT number
DE136636405
EUDAMED status
Active
EUDAMED registered name
GONOTEC Gesellschaft für Meß- und Regeltechnik mbH
EUDAMED abbreviated name
GONOTEC
Registered address
10-11, Reuchlinstraße, 10553, Berlin, Germany
Phone
+49(0)30 78095880
PRRC contact
Florian Bornschein(public in EUDAMED)

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • G o n o t e c Gesellschaft für Meß- und Regeltechnik mbH. US

From the company website

Read 18 Oct 2026

Dear Kundin, dear Kunde, we would like to inform you that the following products have been discontinued from our delivery program with effect from 01.07.2025. We accept last orders until 30.06.2025.Freeze point osmometer, model OSMOMAT® 3000basic / sample size 50μl / article No: 32.BFreeze point osmometer, model OSMOMAT® 3000 M / sample size 15μl / article No: 32.02000 Freeze point osmometer, model OSMOMAT® 3000 D-M / sample size 15μl, with printer / article No: 32.12000 accessories, consumable materials und spare parts are still available according to the current price lists. Maintenance, service, repairs und Support of in-service devices are up to a device age of max. 10 years still guaranteed. Please contact our office: contact [email protected]

Translated from the manufacturer's own website. Source

What GONOTEC Gesellschaft für Meß- und Regeltechnik mbH makes

GONOTEC manufactures osmometers, including the OSMOMAT® series for measuring osmolality in clinical and research settings, alongside calibration standards (100–850 mOsmol/kg NaCl/H₂O) and consumables like measuring vessels for osmometer models (e.g., OSMOMAT 3000/030/010). The OSMOREF® is also part of its portfolio for osmolality reference applications.

The company’s devices fall under EU Device Class A and In Vitro Diagnostic (IVD) General, with records listed in the EUDAMED registry. GONOTEC is based in Germany.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Frequently asked questions

How many devices does GONOTEC Gesellschaft für Meß- und Regeltechnik mbH have in the registry?

The registry currently lists 12 devices for GONOTEC Gesellschaft für Meß- und Regeltechnik mbH. Devices recorded under merged duplicate company entries are counted once.

Which registries list GONOTEC Gesellschaft für Meß- und Regeltechnik mbH's devices?

Among its 12 most recently registered devices, GONOTEC Gesellschaft für Meß- und Regeltechnik mbH has devices listed in EUDAMED (12 devices) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do GONOTEC Gesellschaft für Meß- und Regeltechnik mbH's devices fall under?

Among its 12 most recently registered devices, the classes recorded for GONOTEC Gesellschaft für Meß- und Regeltechnik mbH's devices are IVDR Class A and IVD general. Each device page shows its own class and authorisation.

What are the newest devices from GONOTEC Gesellschaft für Meß- und Regeltechnik mbH in the registry?

The most recently registered devices listed for GONOTEC Gesellschaft für Meß- und Regeltechnik mbH include OSMOMAT®, Calibration Standard 2000mOsmol/kg NaCl/H2O, Calibration Standard 300mOsmol/kg NaCl/H2O and OSMOREF®.

Which FDA establishments are linked to GONOTEC Gesellschaft für Meß- und Regeltechnik mbH?

1 FDA establishment is linked to GONOTEC Gesellschaft für Meß- und Regeltechnik mbH in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.