Delft AI B.V.

Certificate 44911230948

Rev. 2Supplemented

Valid until: Sep 28, 2030

Certificate 44911230948 is a valid Quality management system issued to Delft AI B.V. and registered in EUDAMED. Valid until September 28, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 44911230948
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0044449112309482

Validity

Issued: Oct 9, 2025
Valid from: Oct 9, 2025
Valid until: Sep 28, 2030

Notified body

Notified body: TÜV NORD CERT GmbH
Notified body SRN: 0044
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: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

44911230948Quality management systemIssuedSep 29, 2025 → Sep 28, 2030

Scope coverage

Class IIb1

1 scope

MDA 0315: Software; EMDN: Z12159092: Varous Pneumology and Respiratory Physiopathology Instruments - Medical Device Software
Class IIb

Documents

LanguagesEN