EXBIO Praha, a.s.

Certificate 2025-IVDR/QS-002

Rev. 00Issued

Valid until: Jun 11, 2029

Certificate 2025-IVDR/QS-002 is a valid Quality management system issued to EXBIO Praha, a.s. and registered in EUDAMED. Valid until June 11, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 2025-IVDR/QS-002
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 22652025-IVDR/QS-00200

Validity

Issued: Jun 30, 2025
Valid from: Jun 30, 2025
Valid until: Jun 11, 2029

Manufacturer

Manufacturer: EXBIO Praha, a.s.
Manufacturer SRN: CZ-MF-000033468
Manufacturer country: Czechia

Notified body

Notified body
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

BasoFlowEx KitIVDR Class B
859420806ED704364

Characteristics

Sterile: No
Human tissues: Yes
Animal tissues: No
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class B2

2 scopes

REAGENTS FOR FLOW CYTOMETRY - OTHER
IVDR Class B
DEVICE
IVDR Class B

Documents

LanguagesCSEN