Odontokoala s.r.l.
Italy IT-MF-000054661 Last updated 17 Sep 2026
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- Devices
- 2
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
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.
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.
Information
- Country
- Italy
- Address
- 58, Via della Mendola, Roma, Italy
- Website
- filtrokoala.it
- [email protected]
- PRRC contact
- Maura Petroni
- EUDAMED SRN
- IT-MF-000054661