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GreenBone Ortho Spa

Italy IT-MF-000033034 Last updated 21 Oct 2026

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Devices
40
Registries
EUDAMED
FDA recalls
0

Catalogue40

  • b.Bone Ref GR102010PS

    Class III EUDAMED Active

  • b.Bone Ref HC251340PS

    Class III EUDAMED Active

  • b.Bone Ref HC201030PS

    Class III EUDAMED Active

  • b.Bone Ref HP501520PS

    Class III EUDAMED Active

  • b.Bone Ref HC150640PS

    Class III EUDAMED Active

  • b.Bone Ref HP201020PS

    Class III EUDAMED Active

  • b.Bone Ref HC100030PS

    Class III EUDAMED Active

  • b.Bone Ref WE134030PS

    Class III EUDAMED Active

  • b.Bone Ref HP201520PS

    Class III EUDAMED Active

  • b.Bone Ref HC100010PS

    Class III EUDAMED Active

  • b.Bone Ref GR051010PS

    Class III EUDAMED Active

  • b.Bone Ref HP200510PS

    Class III EUDAMED Active

  • b.Bone Ref HP201530PS

    Class III EUDAMED Active

  • b.Bone Ref HC150650PS

    Class III EUDAMED Active

  • b.Bone Ref GR051015PS

    Class III EUDAMED Active

  • b.Bone Ref HP201030PS

    Class III EUDAMED Active

  • b.Bone Ref HC301560PS

    Class III EUDAMED Active

  • b.Bone Ref HC251310PS

    Class III EUDAMED Active

  • b.Bone Ref HP500520PS

    Class III EUDAMED Active

  • b.Bone Ref HC301530PS

    Class III EUDAMED Active

  • b.Bone Ref HP300530PS

    Class III EUDAMED Active

  • b.Bone Ref HC301550PS

    Class III EUDAMED Active

  • b.Bone Ref HP300520PS

    Class III EUDAMED Active

  • b.Bone Ref HC251320PS

    Class III EUDAMED Active

  • b.Bone Ref WE133015PS

    Class III EUDAMED Active

  • b.Bone Ref GR204005PS

    Class III EUDAMED Active

  • b.Bone Ref HC301520PS

    Class III EUDAMED Active

  • b.Bone Ref HP501530PS

    Class III EUDAMED Active

  • b.Bone Ref GR204015PS

    Class III EUDAMED Active

  • b.Bone Ref GR102015PS

    Class III EUDAMED Active

  • b.Bone Ref HC150660PS

    Class III EUDAMED Active

  • b.Bone Ref HP301510PS

    Class III EUDAMED Active

  • b.Bone Ref HC150610PS

    Class III EUDAMED Active

  • b.Bone Ref HC100050PS

    Class III EUDAMED Active

  • b.Bone Ref HP501020PS

    Class III EUDAMED Active

  • b.Bone Ref HP401520PS

    Class III EUDAMED Active

  • b.Bone Ref WE114030PS

    Class III EUDAMED Active

  • b.Bone Ref WE094030PS

    Class III EUDAMED Active

  • b.Bone Ref HC100040PS

    Class III EUDAMED Active

  • b.Bone Ref HP400520PS

    Class III EUDAMED Active

EUDAMED certificates1

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

EUDAMED certificates (1)

ITALCERT SRL 0426 1 certificate

  • 044-00-01-MDR Supplemented

    Technical documentation EU MDR

    Issued
    20 Apr 2026
    Expires
    5 Mar 2029
    Reason
    Change approved

Related companies

Notified bodies

About

Greenbone Ortho develops innovative, safe and effective solutions for bone regeneration. Inspired by Nature, created by Innovatiors. Join us

From the manufacturer's own website. Source

What GreenBone Ortho Spa makes

GreenBone Ortho Spa manufactures a range of b.Bone products designed for bone regeneration, likely including synthetic bone graft substitutes or biomaterials for orthopaedic and maxillofacial applications. These devices are intended to support healing in fractures, spinal fusion, or reconstructive surgeries, providing structural support or promoting osteoconductive properties. The portfolio appears to focus on medical-grade biomaterials tailored for surgical use in orthopaedic procedures.

All listed b.Bone devices fall under EU Class III classification, requiring conformity assessment via a Notified Body under the EU MDR. They are registered in the EUDAMED database as compliant with European Union regulations. The company is based in Italy and adheres to regulatory requirements for high-risk medical devices.

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 GreenBone Ortho Spa manufacture?

GreenBone Ortho Spa specialises in developing b.Bone products, which are designed for bone regeneration. These devices are likely synthetic bone graft substitutes or biomaterials used in orthopaedic and maxillofacial surgeries. They are intended to support healing processes in applications such as fractures, spinal fusion, or reconstructive procedures by providing structural support or promoting bone growth.

Where is GreenBone Ortho Spa based, and what regulatory registries list its devices?

GreenBone Ortho Spa is based in Italy. Its devices are registered in the EUDAMED database, which is the official European Union registry for medical devices. This registration ensures compliance with EU regulations, including the EU Medical Device Regulation (MDR).

How are the devices manufactured by GreenBone Ortho Spa classified under EU regulations?

All b.Bone devices from GreenBone Ortho Spa fall under EU Class III classification. This classification applies to high-risk medical devices that require rigorous conformity assessment, including involvement of a Notified Body, to ensure safety and performance before market placement.

Why are GreenBone Ortho Spa’s devices listed in EUDAMED?

GreenBone Ortho Spa’s devices are listed in EUDAMED because it is a mandatory requirement under the EU Medical Device Regulation (MDR) for manufacturers to register their high-risk Class III devices in this database. EUDAMED serves as a transparent public record of device information, ensuring traceability and compliance with EU regulatory standards.

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

Information

Country
Italy
Address
8, Albert Einstein , Faenza , Italy
Phone
+39 054646666
PRRC contact
Vanessa Bonomi
EUDAMED SRN
IT-MF-000033034