CB21 Pharma, s.r.o.

Certificate 2025-MDR/QS-032

Rev. 00Issued

Valid until: Jun 12, 2030

Certificate 2025-MDR/QS-032 is a valid Quality management system issued to CB21 Pharma, s.r.o. and registered in EUDAMED. Valid until June 12, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 2025-MDR/QS-032
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-03200

Validity

Issued: Jun 12, 2025
Valid from: Jun 12, 2025
Valid until: Jun 12, 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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

Oral administration preparations not included in other classes devices
Class IIa
DEVICE
Class IIa