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Odontokoala s.r.l.

Italy IT-MF-000054661 Last updated 17 Sep 2026

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Devices
2
Registries
EUDAMED
FDA recalls
0

Catalogue2

  • Intro Ref Intro

    Class I EUDAMED Active
  • Easy Ref 0,1

    Class I EUDAMED Active

What Odontokoala s.r.l. makes

Odontokoala s.r.l. manufactures dental devices, including the Intro and Easy products, which appear to be low-risk instruments or tools for oral healthcare procedures.

These devices are classified as Class I under EU regulations and are listed in the eudamed database. The company is based in Italy.

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 Odontokoala s.r.l. manufacture?

Odontokoala s.r.l. specializes in dental devices, specifically low-risk instruments or tools designed for oral healthcare procedures. Examples include the Intro and Easy products, which are likely intended for routine dental applications.

Where is Odontokoala s.r.l. based?

Odontokoala s.r.l. is headquartered in Italy, as indicated by its company registration. This location is relevant for regulatory compliance and market access within the EU.

Which regulatory registries list Odontokoala s.r.l.’s devices?

Odontokoala s.r.l.’s devices are listed in the eudamed database, which is the EU’s central registry for medical devices. This inclusion helps ensure transparency and traceability of Class I devices under EU regulations.

How are Odontokoala s.r.l.’s devices classified under EU regulations?

Odontokoala s.r.l.’s devices fall under Class I classification, which applies to low-risk products like dental instruments or tools. This classification determines the regulatory requirements, such as conformity assessment procedures, that must be followed.

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

Information

Country
Italy
Address
58, Via della Mendola, Roma, Italy
PRRC contact
Maura Petroni
EUDAMED SRN
IT-MF-000054661