NORAKER

Certificate 39086

Rev. 6Supplemented

Valid until: May 29, 2027

Certificate 39086 is a valid Quality management system issued to NORAKER and registered in EUDAMED. Valid until May 29, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 39086
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0459390866

Validity

Issued: May 27, 2026
Valid from: May 27, 2026
Valid until: May 29, 2027

Notified body

Notified body: GMED SAS
Notified body SRN: 0459
Notified body country: France

Covered devices

No specific devices are listed for this certificate.

Characteristics

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

History

Status changes

Supplemented

Supersedes

39086SupplementedJun 20, 2025 → May 29, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class III1

1 scope

Dispositif implantable résorbable stérile destiné à la substitution osseuse Sterile resorbable implantable device intended for the bone replacement
Class III