Shanghai HeartCare Medical Technology Corporation Limited

Certificate M.2023.MDR.1027-1

Rev. 00Issued

Valid until: Nov 13, 2026

Certificate M.2023.MDR.1027-1 — a Technical documentation issued to Shanghai HeartCare Medical Technology Corporation Limited — is approaching its expiry. Valid until November 13, 2026. View the full certificate record on MD Atlas.

Overview

Certificate number: M.2023.MDR.1027-1
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2696M.2023.MDR.1027-100

Validity

Issued: Nov 14, 2023
Valid from: Nov 14, 2023
Valid until: Nov 13, 2026

Manufacturer

Manufacturer: Shanghai HeartCare Medical Technology Corporation Limited
Manufacturer SRN: CN-MF-000001941
Manufacturer country: China

Notified body

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

Covered devices

Thrombectomy DeviceClass III
697114548TDERF

Linked SSCPs

SSCP TF.TDE-SSCP01

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
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

No status changes or preceding certificates are recorded.

Scope coverage

Class III1

1 scope

Thrombectomy Device
Class III
697114548TDERF

Documents

LanguagesEN