Question 1

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

Accepted Answer

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.

Question 2

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

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
X-Cogni	17501102	EUDAMED	Class I	Active
Tnch-3	15501103	EUDAMED	Class I	Active
Capri	17501101	EUDAMED	Class I	Active
Gamma	17.501.202	EUDAMED	Class I	Active
Platinium	08501201	EUDAMED	Class IIa	Active
Cubito	17501303	EUDAMED	Class I	Active
Magellan	01501210	EUDAMED	Class IIa	Active
Vectis Mini	17501302	EUDAMED	Class I	Active
Ametyst	13501301	EUDAMED	Class I	Active
Vectis	17501301	EUDAMED	Class I	Active
Manus	13501303	EUDAMED	Class I	Active
Beryl Ii	14501206	EUDAMED	Class I	Active
Telko	17501304	EUDAMED	Class I	Active
Castillo	01501416	EUDAMED	Class IIa	Active
Jupiter	17501305	EUDAMED	Class I	Active
T-Mp Uwm Automat	01501202	EUDAMED	Class IIa	Active
Sigma	17.501.203	EUDAMED	Class I	Active
Levitas 1	13501201	EUDAMED	Class I	Active
Levitas 3	13501203	EUDAMED	Class I	Active
Mirr-3	13501402	EUDAMED	Class I	Active
Froozer	06501010	EUDAMED	Class IIa	Active
T-Mp	01501204	EUDAMED	Class IIa	Active
Korund-E	14501207	EUDAMED	Class I	Active
T-Uwm	01501201	EUDAMED	Class IIa	Active
Granit	14501205	EUDAMED	Class I	Active
T-Np	01501610	EUDAMED	Class IIa	Active
T-Alter	01501603	EUDAMED	Class IIa	Active
Gravispine	08501301	EUDAMED	Class I	Active
Mirr-1	13501401	EUDAMED	Class I	Active
Tnch-2	15501102	EUDAMED	Class I	Active
Sch-2	15501105	EUDAMED	Class I	Active
Saturator Co2	01501602	EUDAMED	Class IIa	Active
T-Mot	01501220	EUDAMED	Class IIa	Active
Mini Tensor	17501306	EUDAMED	Class I	Active
T-Agre	01501609	EUDAMED	Class IIa	Active
X-Visio Pro	17501401	EUDAMED	Class I	Active
Onyks	14501202	EUDAMED	Class I	Active
Alfa	17.501.201	EUDAMED	Class I	Active
Topaz	14501204	EUDAMED	Class I	Active
Tasman	01501505	EUDAMED	Class IIa	Active
Ostium	13501501	EUDAMED	Class I	Active
Azuryt Ii	13501802	EUDAMED	Class I	Active
1114	01501401	EUDAMED	Class IIa	Active
T-Mp Discovery	01501214	EUDAMED	Class IIa	Active
Beryl	14501203	EUDAMED	Class I	Active
Pizarro	01501420	EUDAMED	Class IIa	Active
Tf-204	14501102	EUDAMED	Class I	Active
1117	01501409	EUDAMED	Class IIa	Active
Opal	14501201	EUDAMED	Class I	Active
Mobilux	18501301	EUDAMED	Class I	Active

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

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