Hamilton Medical AG

Certificate HZ 1093044-1

Rev. Rev. 4Reissued

Valid until: Dec 23, 2030

Certificate HZ 1093044-1 is a valid Quality management system issued to Hamilton Medical AG and registered in EUDAMED. Valid until December 23, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1093044-1
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 1093044-1Rev. 4

Validity

Issued: Dec 12, 2025
Valid from: Dec 24, 2025
Valid until: Dec 23, 2030

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

History

Supersedes

HZ 1093044-1Quality management systemSupplementedJan 12, 2024 → Dec 23, 2025

Scope coverage

Class IIb2Class IIa1Class III1

4 scopes

R9099 - Respiratory and Anaesthesia Devices – Others R020101 - Breathing Circuits, Standard R020102 - Breathing Circuits, Coaxial R030102 - Air/Oxygen Masks and Nasal Cannulas
Class IIa
R9099 - Respiratory and Anaesthesia Devices – Others
Class IIb
Z120301 - Anaesthesia and Pulmonary Ventilation Support Instruments
Class III
R060201 – Humidification Systems Active Ventilation Humidification Systems
Class IIb

Documents

LanguagesEN