AQUATOOLS

Certificate 40035

Rev. 1Supplemented

Valid until: Feb 1, 2028

Certificate 40035 is a valid Quality management system issued to AQUATOOLS and registered in EUDAMED. Valid until February 1, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 40035
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0459400351

Validity

Issued: Apr 22, 2026
Valid from: Apr 22, 2026
Valid until: Feb 1, 2028

Manufacturer

Manufacturer: AQUATOOLS
Manufacturer SRN: FR-MF-000028808
Manufacturer country: France

Notified body

Notified body
Notified body SRN: 0459
Notified body country: France

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

40035IssuedOct 15, 2024 → Feb 1, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class I1

1 scope

Filtre à usage unique, stérile, pour la distribution d’eau bactériologiquement maitrisée, visant la protection des patients immunodéprimés. Disposable water filter, sterile, for the distribution of bacteriologically controlled water, for the protection of immunocompromised patients
Class I

Documents

LanguagesENFR