Alleva Medical Limited

Certificate M.2024.MDR.1041

Rev. 01Amended

Valid until: Jun 25, 2029

Certificate M.2024.MDR.1041 is a valid Quality management system issued to Alleva Medical Limited and registered in EUDAMED. Valid until June 25, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: M.2024.MDR.1041
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 2696M.2024.MDR.104101

Validity

Issued: Sep 29, 2025
Valid from: Sep 29, 2025
Valid until: Jun 25, 2029

Notified body

Notified body: UDEM Adriatic d.o.o.
Notified body SRN: 2696
Notified body country: Croatia

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
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: No
QMS/MOS type: Others

History

Status changes

Amended
Amended

Supersedes

M.2024.MDR.1041Quality management systemIssuedJun 26, 2024 → Jun 25, 2029

Scope coverage

Class IIa1

1 scope

extriCARE® Negative Pressure Wound Therapy Pump
Class IIa

Documents

LanguagesEN