Fraiya Ltd

Certificate SCAR-4.2.1.1

Amended

Valid until: Jul 31, 2030

Certificate SCAR-4.2.1.1 is a valid Quality management system issued to Fraiya Ltd and registered in EUDAMED. Valid until July 31, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: SCAR-4.2.1.1
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 3022SCAR-4.2.1.1

Validity

Issued: May 26, 2026
Valid from: May 26, 2026
Valid until: Jul 31, 2030

Manufacturer

Manufacturer: Fraiya Ltd
Manufacturer SRN: UK-MF-000045978
Manufacturer country: United Kingdom

Notified body

Notified body
Notified body SRN: 3022
Notified body country: Netherlands

Covered devices

FraiyaScanClass IIa
5061081485061081480001Q5

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

SCAR-4.2.1.0IssuedAug 1, 2025 → Jul 31, 2030

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa2

2 scopes

MDA 0315 - Software
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN