Löwenstein Medical Technology GmbH + Co. KG

Certificate HZ 1010032-1

Rev. 3Issued

Valid until: Mar 10, 2025

Certificate HZ 1010032-1, a Quality management system issued to Löwenstein Medical Technology GmbH + Co. KG, has expired. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1010032-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 1010032-13

Validity

Issued: Feb 3, 2023
Valid from: Feb 3, 2023
Valid until: Mar 10, 2025

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: Yes
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

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1Class IIb1

2 scopes

R9099 - RESPIRATORY AND ANAESTHESIA DEVICES - OTHER R030101 - VENTILATION MASKS
Class IIa
R9099 - RESPIRATORY AND ANAESTHESIA DEVICES - OTHER
Class IIb

Documents

LanguagesEN