Hamilton Bonaduz AG

Certificate HX 1774385-1

Rev. Rev. 0Issued

Valid until: Sep 15, 2029

Certificate HX 1774385-1 is a valid Quality management system issued to Hamilton Bonaduz AG and registered in EUDAMED. Valid until September 15, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 1774385-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0197HX 1774385-1Rev. 0

Validity

Issued: Sep 16, 2024
Valid from: Sep 16, 2024
Valid until: Sep 15, 2029

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: Yes
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class A1

1 scope

IVR 0801: Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746 W0580 - IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
IVDR Class A

Documents

LanguagesEN