Aroa Biosurgery Ltd.

Certificate 3829441CE01

Rev. 1Supplemented

Valid until: Feb 20, 2031

Certificate 3829441CE01 is a valid Quality management system issued to Aroa Biosurgery Ltd. and registered in EUDAMED. Valid until February 20, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: 3829441CE01
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03443829441CE011

Validity

Issued: May 26, 2026
Valid from: May 26, 2026
Valid until: Feb 20, 2031

Manufacturer

Manufacturer: Aroa Biosurgery Ltd.
Manufacturer SRN: NZ-MF-000003726
Manufacturer country: New Zealand

Notified body

Notified body
Notified body SRN: 0344
Notified body country: Netherlands

Covered devices

Characteristics

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

History

Status changes

Supplemented

Supersedes

3829441CE01IssuedFeb 20, 2026 → Feb 20, 2031

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class III2

2 scopes

DEVICE
Class III
DEVICE
Class III

Documents

LanguagesEN