Medeia Group Ltd

Certificate HU26/00000012

Rev. 1Issued

Valid until: Feb 6, 2030

Certificate HU26/00000012 is a valid Quality management system issued to Medeia Group Ltd and registered in EUDAMED. Valid until February 6, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HU26/00000012
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1639HU26/000000121

Validity

Issued: Feb 10, 2026
Valid from: Feb 10, 2026
Valid until: Feb 6, 2030

Notified body

Notified body: SGS Belgium NV
Notified body SRN: 1639
Notified body country: Belgium

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: 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: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

MDA 0203, MDS1009
Class IIa
VitalScan ANS (HW10) Electrocardiograph and Plethysmograph measurement device for assessment of Cardiovascular and Autonomic Nervous System and for assessing possible presence of peripheral arterial disease (PAD) Basic UDI-DI: 197644300693HW10TH
Class IIa

Documents

LanguagesEN