Bionet Co., Ltd.

Certificate 2023-MDR/QS-030

Rev. 00Issued

Valid until: Oct 10, 2028

Certificate 2023-MDR/QS-030 is a valid Quality management system issued to Bionet Co., Ltd. and registered in EUDAMED. Valid until October 10, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 2023-MDR/QS-030
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-03000

Validity

Issued: Oct 10, 2023
Valid from: Oct 10, 2023
Valid until: Oct 10, 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: 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

Handheld ultrasound scanners
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN