Löwenstein Medical Innovation GmbH & Co. KG

Certificate G10 012094 0035

Rev. Rev. 02Supplemented

Valid until: Aug 5, 2031

Certificate G10 012094 0035 is a valid Quality management system issued to Löwenstein Medical Innovation GmbH & Co. KG and registered in EUDAMED. Valid until August 5, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 012094 0035
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 012094 0035Rev. 02

Validity

Issued: Jul 10, 2026
Valid from: Aug 6, 2026
Valid until: Aug 5, 2031

Manufacturer

Manufacturer: Löwenstein Medical Innovation GmbH & Co. KG
Manufacturer SRN: DE-MF-000016838
Manufacturer country: Germany

Notified body

Notified body
Notified body SRN: 0123
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

History

Status changes

Supplemented

Supersedes

G10 012094 0035SupplementedNov 11, 2025 → Aug 5, 2026

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb2Class IIa1

3 scopes

Z12030105 - PULMONARY VENTILATORS FOR HOSPITAL USE
Class IIb
Z120301 - ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENTS
Class IIb
Z120301 - ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENTS
Class IIa

Documents

LanguagesEN