Cosmonde, a.s.

Certificate 2025-MDR/QS-030/A

Rev. 01Issued

Valid until: May 13, 2030

Certificate 2025-MDR/QS-030/A is a valid Quality management system issued to Cosmonde, a.s. and registered in EUDAMED. Valid until May 13, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 2025-MDR/QS-030/A
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652025-MDR/QS-030/A01

Validity

Issued: Feb 10, 2026
Valid from: Feb 10, 2026
Valid until: May 13, 2030

Notified body

Notified body: 3EC International a.s.
Notified body SRN: 2265
Notified body country: Slovakia

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: Basic UDI-DI data and Class IIb

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb6

6 scopes

Protective devices, lubricants and soothing devices (sprays, gels, fluids and creams)
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb