Luciole Medical AG

Certificate 7229GB448240322

Issued

Valid until: Jul 15, 2027

Certificate 7229GB448240322 is a valid Quality management system issued to Luciole Medical AG and registered in EUDAMED. Valid until July 15, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 7229GB448240322
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 04827229GB448240322

Validity

Issued: Mar 22, 2024
Valid from: Mar 22, 2024
Valid until: Jul 15, 2027

Manufacturer

Manufacturer: Luciole Medical AG
Manufacturer SRN: CH-MF-000015856
Manufacturer country: Switzerland

Notified body

Notified body: DNV MEDCERT GmbH
Notified body SRN: 0482
Notified body country: Germany

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: 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 IIa2Class III1

3 scopes

MDA 0203 EMDN Z12109006
Class IIa
MDA 0315 EMDN Z12109006
Class IIa
MDN 1201
Class III

Documents

LanguagesEN