ЖИВАС ООД

Certificate 2023-MDR/QS-043

Rev. 00Issued

Valid until: Nov 10, 2028

Certificate 2023-MDR/QS-043 is a valid Quality management system issued to ЖИВАС ООД and registered in EUDAMED. Valid until November 10, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 2023-MDR/QS-043
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-04300

Validity

Issued: Nov 10, 2023
Valid from: Nov 10, 2023
Valid until: Nov 10, 2028

Manufacturer

Manufacturer: ЖИВАС ООД
Manufacturer SRN: BG-MF-000019745
Manufacturer country: Bulgaria

Notified body

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

Covered devices

Glutasept SClass IIb
38002282400957

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 IIb2

2 scopes

Aldehydes for the disinfection of medical devices - other
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN