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IBIS Srl

Italy IT-MF-000024698 Last updated 21 Oct 2026

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Devices
10
Registries
EUDAMED
FDA recalls
0

Catalogue10

  • Neeo S12 Ref 01.18.015.001

    Class IIb EUDAMED Active

  • MatriX evo Ref 01.15.017.001

    Class IIb EUDAMED Active

  • Simply dr Ref 01.15.005.049

    Class IIb EUDAMED Active

  • Simply HP Ref 01.15.005.001

    Class IIb EUDAMED Active

  • MatriX dr Ref 01.15.027.001

    Class IIb EUDAMED Active

  • Neeo S9 Ref 01.18.013.001

    Class IIb EUDAMED Active

  • Neeo R12 Ref 01.18.014.001

    Class IIb EUDAMED Active

  • MatriX HP Ref 01.15.003.001

    Class IIb EUDAMED Active

  • Simply evo Ref 01.15.016.001

    Class IIb EUDAMED Active

  • Neeo R9 Ref 01.18.012.001

    Class IIb EUDAMED Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

Notified body 0051 1 certificate

  • 159/MDR Supplemented

    Quality management system EU MDR

    Issued
    13 Oct 2025
    Expires
    5 Mar 2029
    Reason
    Add device or group

Related companies

Notified bodies

  • Notified body 0051

About

IBIS designs and manufactures medical equipment for both human and veterinary applications. Contact us for information.

Translated from the manufacturer's own website. Source

What IBIS Srl makes

IBIS Srl manufactures dental radiography systems, including intraoral and panoramic X-ray devices. Their portfolio includes digital sensors, control units, and associated software for capturing and processing radiographic images in both human and veterinary dentistry.

These devices fall under EU Class IIb classification and are registered in the EUDAMED database. The company is based in Italy and adheres to relevant European regulatory requirements for medical imaging equipment.

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 IBIS Srl manufacture?

IBIS Srl specializes in dental radiography systems, including intraoral and panoramic X-ray devices. Their product range includes digital sensors, control units, and software for capturing and processing radiographic images. These devices are designed for both human and veterinary dental applications, enabling precise imaging for diagnostic purposes.

Where is IBIS Srl based, and what regulatory region does it operate in?

IBIS Srl is based in Italy and operates within the European Union regulatory framework. Their devices are designed to comply with EU medical device regulations, ensuring they meet the necessary safety, performance, and quality standards for commercialization in the EU market.

Which regulatory databases list IBIS Srl’s devices?

IBIS Srl’s devices are registered in the EUDAMED database, which is the official European Union database for medical devices. Registration in EUDAMED is required for devices placed on the EU market, ensuring transparency and traceability of medical devices across the region.

How are IBIS Srl’s devices classified under EU regulations?

IBIS Srl’s dental radiography systems fall under EU Class IIb classification. This classification is assigned based on the risk associated with the device—Class IIb devices pose moderate to high risks and require additional scrutiny, including conformity assessment procedures, to ensure their safety and performance before being placed on the market.

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

Information

Country
Italy
Address
1, Via San Francesco d'Assisi, Bergamo, Italy
Phone
+39 0354236343
PRRC contact
Michael Terzi
EUDAMED SRN
IT-MF-000024698