EXBIO Praha, a.s.

Certificate 2024-IVDR/QS-004

Rev. 01Supplemented

Valid until: Jun 11, 2029

Certificate 2024-IVDR/QS-004 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: 2024-IVDR/QS-004
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 22652024-IVDR/QS-00401

Validity

Issued: Dec 4, 2024
Valid from: Dec 4, 2024
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

Characteristics

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

History

Status changes

Supplemented

Supersedes

2024-IVDR/QS-004IssuedJun 11, 2024 → Jun 11, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

IVDR Class C7

7 scopes

MONOCLONAL ANTIBODIES / FLOW CYTOMETRY
IVDR Class C
DEVICE
IVDR Class C
DEVICE
IVDR Class C
DEVICE
IVDR Class C
DEVICE
IVDR Class C
DEVICE
IVDR Class C
DEVICE
IVDR Class C

Documents

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