EDAP TMS FRANCE

Certificate 39982

Rev. 2Supplemented

Valid until: Sep 1, 2029

Certificate 39982 is a valid Quality management system issued to EDAP TMS FRANCE and registered in EUDAMED. Valid until September 1, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 39982
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0459399822

Validity

Issued: Jun 22, 2026
Valid from: Jun 22, 2026
Valid until: Sep 1, 2029

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: 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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

39982SupplementedMar 20, 2025 → Sep 1, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa1Class IIb1

1 scope

Appareils robotisés de thérapie par ultrasons de haute intensité et accessoires associés Robotic high intensity ultrasound therapy equipment and associated accessories
Class IIaClass IIb