HCI Solutions AG

Certificate 1000226650

Issued

Valid until: Dec 10, 2030

Certificate 1000226650 is a valid Quality management system issued to HCI Solutions AG and registered in EUDAMED. Valid until December 10, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 1000226650
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 02971000226650

Validity

Issued: Dec 11, 2025
Valid from: Dec 11, 2025
Valid until: Dec 10, 2030

Manufacturer

Manufacturer: HCI Solutions AG
Manufacturer SRN: CH-MF-000044367
Manufacturer country: Switzerland

Notified body

Notified body: DQS Medizinprodukte GmbH
Notified body SRN: 0297
Notified body country: Germany

Covered devices

Documedis CDS.CEClass IIa
7649998068CDSRM

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: Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

MDA 0315 - Software
Class IIa
DEVICE
Class IIa

Documents

LanguagesDEEN