ALLISONE TECHNOLOGIES

Certificate C724122

Rev. 1Issued

Valid until: May 8, 2030

Certificate C724122 is a valid Quality management system issued to ALLISONE TECHNOLOGIES and registered in EUDAMED. Valid until May 8, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: C724122
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2460C7241221

Validity

Issued: May 8, 2025
Valid from: May 8, 2025
Valid until: May 8, 2030

Manufacturer

Manufacturer: ALLISONE TECHNOLOGIES
Manufacturer SRN: FR-MF-000020951
Manufacturer country: France

Notified body

Notified body: DNV Product Assurance AS
Notified body SRN: 2460
Notified body country: Norway

Covered devices

No specific devices are listed for this certificate.

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

Software as a service that analyzes dental X-rays in order to support dentists in their diagnosis
Class IIa
ALLISONE AI SW Ver. 2
Class IIa

Documents

LanguagesEN