LASAK s.r.o.

Certificate 2023-MDR/QS-038/A

Rev. 2Supplemented

Valid until: Oct 27, 2028

Certificate 2023-MDR/QS-038/A is a valid Quality management system issued to LASAK s.r.o. and registered in EUDAMED. Valid until October 27, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 2023-MDR/QS-038/A
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 22652023-MDR/QS-038/A2

Validity

Issued: Jun 10, 2025
Valid from: Jun 10, 2025
Valid until: Oct 27, 2028

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: No
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: No
QMS/MOS type: Basic UDI-DI data and Class IIb

History

Status changes

Supplemented

Supersedes

2023-MDR/QS-038/AQuality management systemIssuedJun 10, 2025 → Oct 27, 2028

Scope coverage

Class IIb14Class IIa6

19 scopes

Dental implants - accessories
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