Medical Impact

Certificate 2024-MDR/TD-052/A

Rev. 01Supplemented

Valid until: Aug 28, 2029

Certificate 2024-MDR/TD-052/A is a valid Technical documentation issued to Medical Impact and registered in EUDAMED. Valid until August 28, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 2024-MDR/TD-052/A
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 22652024-MDR/TD-052/A01

Validity

Issued: Jan 14, 2026
Valid from: Jan 14, 2026
Valid until: Aug 28, 2029

Manufacturer

Manufacturer: Medical Impact
Manufacturer SRN: KR-MF-000030613
Manufacturer country: South Korea

Notified body

Notified body
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing DeviceClass III
88000216EZ9W

Characteristics

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

History

Status changes

Supplemented

Supersedes

2024-MDR/TD-052Technical documentationIssuedAug 28, 2024 → Aug 28, 2029

Scope coverage

Unspecified1

1 scope

EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device
88000216EZ9W

Documents

LanguagesEN