MEDIN, a.s.

Certificate 2023-MDR/QS-028

Rev. 0Issued

Valid until: Aug 31, 2028

Certificate 2023-MDR/QS-028 is a valid Quality management system issued to MEDIN, a.s. and registered in EUDAMED. Valid until August 31, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 2023-MDR/QS-028
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652023-MDR/QS-0280

Validity

Issued: Aug 31, 2023
Valid from: Aug 31, 2023
Valid until: Aug 31, 2028

Notified body

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

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: 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 IIb2

2 scopes

Intramedullary nails
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN