Optellum Ltd

Certificate MDR 748632

Rev. R001Amended

Valid until: Mar 6, 2027

Certificate MDR 748632 is a valid Quality management system issued to Optellum Ltd and registered in EUDAMED. Valid until March 6, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR 748632
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2797MDR 748632R001

Validity

Issued: Jun 30, 2026
Valid from: Jun 30, 2026
Valid until: Mar 6, 2027

Manufacturer

Manufacturer: Optellum Ltd
Manufacturer SRN: GB-MF-000002862
Manufacturer country: United Kingdom

Notified body

Notified body
Notified body SRN: 2797
Notified body country: Netherlands

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: No
Intended medical purpose: No
SPP applicable

History

Status changes

Amended

Supersedes

MDR 748632AmendedAug 8, 2025 → Mar 6, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb1

1 scope

Computed tomography scanning systems (CT) - Software
Class IIb

Documents

LanguagesEN