Bionet Co., Ltd.

Certificate 2024-MDR/QS-053/A

Rev. 02Supplemented

Valid until: Sep 12, 2029

Certificate 2024-MDR/QS-053/A is a valid Quality management system issued to Bionet Co., Ltd. and registered in EUDAMED. Valid until September 12, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 2024-MDR/QS-053/A
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652024-MDR/QS-053/A02

Validity

Issued: Mar 10, 2026
Valid from: Mar 10, 2026
Valid until: Sep 12, 2029

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

Status changes

Supplemented

Supersedes

2024-MDR/QS-053SupplementedFeb 28, 2025 → Sep 12, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa2

2 scopes

Electrocardiographs
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN