Ingenion Medical Ltd.

Certificate ECM24MDR002

Rev. 1Supplemented

Valid until: Mar 27, 2029

Certificate ECM24MDR002 is a valid Quality management system issued to Ingenion Medical Ltd. and registered in EUDAMED. Valid until March 27, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: ECM24MDR002
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1282ECM24MDR0021

Validity

Issued: Jan 20, 2025
Valid from: Jan 20, 2025
Valid until: Mar 27, 2029

Manufacturer

Manufacturer: Ingenion Medical Ltd.
Manufacturer SRN: UK-MF-000041065
Manufacturer country: United Kingdom

Notified body

Notified body
Notified body SRN: 1282
Notified body country: Italy

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

History

Status changes

Supplemented

Supersedes

ECM24MDR002Quality management systemIssuedMar 28, 2024 → Mar 27, 2029

Scope coverage

Class IIb1

1 scope

DEVICE
Class IIb

Documents

LanguagesENIT