SOPRO

Certificate 39219

Rev. 4Restricted

Valid until: Dec 26, 2027

Certificate 39219 is a valid Quality management system issued to SOPRO and registered in EUDAMED. Valid until December 26, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 39219
Certificate type: Quality management system
Certificate status: Restricted
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0459392194

Validity

Issued: Jun 12, 2026
Valid from: Jun 12, 2026
Valid until: Dec 26, 2027

Manufacturer

Manufacturer: SOPRO
Manufacturer SRN: FR-MF-000000833
Manufacturer country: France

Notified body

Notified body
Notified body SRN: 0459
Notified body country: France

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

History

Status changes

Restricted

Supersedes

39219SupplementedNov 14, 2024 → Dec 26, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa1

1 scope

Système numérique de radiologie Radiological digital system
Class IIa

Documents

LanguagesENFR