Aurena Laboratories AB

Certificate 28620131862

Rev. 04Issued

Valid until: Oct 27, 2027

Certificate 28620131862 is a valid Quality management system issued to Aurena Laboratories AB and registered in EUDAMED. Valid until October 27, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 28620131862
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 28622862013186204

Validity

Issued: Jun 10, 2026
Valid from: Jun 10, 2026
Valid until: Oct 27, 2027

Notified body

Notified body: Intertek Medical Notified Body AB
Notified body SRN: 2862
Notified body country: Sweden

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
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: —
QMS/MOS type: Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa13

13 scopes

Non-sterile solutions and gels for skin care
Class IIa
Sterile saline solutions (wound wash, nasal sprays, and eye and ear solutions)
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN