Aerolite AG

Certificate G15 097666 0005

Rev. Rev. 00Reissued

Valid until: Sep 19, 2031

Certificate G15 097666 0005 is a valid Quality management system issued to Aerolite AG and registered in EUDAMED. Valid until September 19, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: G15 097666 0005
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G15 097666 0005Rev. 00

Validity

Issued: Jun 22, 2026
Valid from: Sep 20, 2026
Valid until: Sep 19, 2031

Manufacturer

Manufacturer: Aerolite AG
Manufacturer SRN: CH-MF-000013572
Manufacturer country: Switzerland

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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

Supersedes

G10 097666 0004Quality management systemIssuedApr 9, 2024 → Sep 19, 2026

Scope coverage

Class IIb1Class IIa1

2 scopes

Z120309 - MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES
Class IIb
MDA 0316 - Medical gas supply systems and parts thereof
Class IIa

Documents

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