Zhejiang Barty Medical Technology Co., Ltd.

Certificate M.2025.MDR.1072

Rev. 01Supplemented

Valid until: May 14, 2028

Certificate M.2025.MDR.1072 is a valid Quality management system issued to Zhejiang Barty Medical Technology Co., Ltd. and registered in EUDAMED. Valid until May 14, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: M.2025.MDR.1072
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 2696M.2025.MDR.107201

Validity

Issued: May 18, 2026
Valid from: May 18, 2026
Valid until: May 14, 2028

Manufacturer

Manufacturer: Zhejiang Barty Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000007977
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 2696
Notified body country: Croatia

Covered devices

No specific devices are listed for this certificate.

Characteristics

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

History

Status changes

Supplemented
Supplemented

Supersedes

M.2025.MDR.1072Quality management systemIssuedMay 15, 2025 → May 14, 2028

Scope coverage

Class III1

1 scope

Sterile PTCA Balloon Catheter ) BASIC UDI DI: (69277410ZBT0001TB)
Class III

Documents

LanguagesEN