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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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MD Atlas
Documents

GreenBone Ortho Spa

Certificate 044-00-01-MDR

Rev. 01Supplemented

Valid until: Mar 5, 2029

Overview

Certificate number: 044-00-01-MDR
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0426044-00-01-MDR01

Validity

Issued: Apr 20, 2026
Valid from: Apr 20, 2026
Valid until: Mar 5, 2029

Manufacturer

Manufacturer: GreenBone Ortho Spa
Manufacturer SRN: IT-MF-000033034
Manufacturer country: Italy

Notified body

Notified body: ITALCERT SRL
Notified body SRN: 0426
Notified body country: Italy

Covered devices

b.BoneClass III
805384834IP01R3D01M01DD

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
In vitro diagnostics: —
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

044-00-00-MDRTechnical documentationIssuedMar 6, 2024 → Mar 5, 2029

Scope coverage

Unspecified1

1 scope

b.Bone
805384834IP01R3D01M01DD

Documents

LanguagesENIT