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Przedsiębiorstwo Handlowo-Usługowe "Technomex" Sp. z o.o.

Poland·PL-MF-000038261

Last updated September 17, 2026

About

We help with technology. We support the development of facilities: medical, rehabilitation, sports, educational. We provide equipment, comprehensive solutions and concepts.

Translated from the manufacturer's own website. Source

What Przedsiębiorstwo Handlowo-Usługowe "Technomex" Sp. z o.o. makes

The company manufactures reusable dental drill bits and rubber dam clamps made from Hevea-latex, including branded models like X-COGNI, TNCH-3, CAPRI, and others. These products are designed for dental procedures, with drill bits intended for fixture or appliance use and rubber dams for isolation in treatments.

The portfolio includes devices classified as Class I and Class IIa under EU regulations, all of which are registered in the eudamed database. The manufacturer is based in Poland.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Przedsiębiorstwo Handlowo-Usługowe 'Technomex' Sp. z o.o. manufacture?

Przedsiębiorstwo Handlowo-Usługowe 'Technomex' Sp. z o.o. specialises in reusable dental tools, specifically fixture or appliance dental drill bits and rubber dam clamps made from Hevea-latex. These devices are designed for use in dental procedures, with drill bits for precision applications and rubber dams for isolating treatment areas. Examples include branded models like X-COGNI, TNCH-3, CAPRI, and others.

Where is Przedsiębiorstwo Handlowo-Usługowe 'Technomex' Sp. z o.o. based?

The company is based in Poland, as indicated by its country designation. This location is relevant for regulatory compliance and distribution within the European market.

Which regulatory registries list the devices manufactured by Przedsiębiorstwo Handlowo-Usługowe 'Technomex' Sp. z o.o.?

The devices produced by the company are registered in the eudamed database, which is the European Union’s central registry for medical devices. This ensures transparency and traceability of their products under EU regulatory frameworks.

How are the devices manufactured by Przedsiębiorstwo Handlowo-Usługowe 'Technomex' Sp. z o.o. classified under EU regulations?

The company’s devices fall into two classification categories under EU medical device regulations: Class I and Class IIa. Classification depends on factors like risk level, intended use, and duration of contact with the patient. For example, reusable dental drill bits and rubber dams are typically assessed based on their purpose and potential risks in clinical settings.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Poland
Address
15, Szparagowa, Gliwice, Poland
Phone
+48324010350
PRRC Contact
Rafał Kowolik
EUDAMED SRN
PL-MF-000038261
FDA FEI Number
—
DUNS Number
—

Catalogue (60)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
Mobilux 18501301
EUDAMED
Class IActive
Levitas 2 13501202
EUDAMED
Class IActive
Toledo 01501302
EUDAMED
Class IIaActive
T-Uwm-E 01501301
EUDAMED
Class IIaActive
Kolumb 01501411
EUDAMED
Class IIaActive
1115 01501405
EUDAMED
Class IIaActive
X-Visio Basic 17501402
EUDAMED
Class IActive
Cordoba 01501607
EUDAMED
Class IIaActive
Sch-1 15501104
EUDAMED
Class IActive
Almagro 01501212
EUDAMED
Class IIaActive
Tnch-1 15501101
EUDAMED
Class IActive

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