MAIA LABS s.r.o.

Certificate 2026-MDR/QS-027

Rev. 00Issued

Valid until: May 25, 2031

Certificate 2026-MDR/QS-027 is a valid Quality management system issued to MAIA LABS s.r.o. and registered in EUDAMED. Valid until May 25, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: 2026-MDR/QS-027
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652026-MDR/QS-02700

Validity

Issued: May 25, 2026
Valid from: May 25, 2026
Valid until: May 25, 2031

Manufacturer

Manufacturer: MAIA LABS s.r.o.
Manufacturer SRN: CZ-MF-000044767
Manufacturer country: Czechia

Notified body

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

Covered devices

ColoMaia IIClass IIa
859422543ColoMaiaIINK

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

INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - MEDICAL DEVICE SOFTWARE
Class IIa
DEVICE
Class IIa

Documents

LanguagesCSEN