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Fraiya Ltd

United Kingdom (ex Northern Ireland) UK-MF-000045978 Last updated 22 Oct 2026

Devices
1
Registries
EUDAMED
FDA recalls
0

Catalogue1

  • FraiyaScan Ref FraiyaScan

    Class IIa EUDAMED Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

Notified body 3022 1 certificate

  • SCAR-4.2.1.1 Amended

    Quality management system EU MDR

    Issued
    26 May 2026
    Expires
    31 Jul 2030
    Reason
    Other

Authorised representatives

Notified bodies

  • Notified body 3022

About

FraiyaScan and FraiyaDetect are two AI-powered tools that automate biometry, reduce scan time, and transform every scan into a structured, review-ready workflow.

From the manufacturer's own website. Source

What Fraiya Ltd makes

Fraiya Ltd manufactures FraiyaScan, an AI-powered device designed to automate biometric scanning processes and streamline workflows by converting scans into structured, review-ready formats. The system is intended to reduce the time required for biometric data capture while ensuring consistency and efficiency in the scanning process.

FraiyaScan is classified as a Class IIa medical device and is registered in the EU’s eudamed database. The company is based in the United Kingdom.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Fraiya Ltd manufacture?

Fraiya Ltd manufactures FraiyaScan, an AI-powered medical device designed to automate biometric scanning. It converts scans into structured, review-ready formats to improve efficiency and reduce scan time. The device focuses on streamlining workflows for biometric data capture.

Where is Fraiya Ltd based?

Fraiya Ltd is based in the United Kingdom. The company’s headquarters and operations are located there, which is also where its primary regulatory and commercial activities are centered.

In which regulatory registries are Fraiya Ltd’s devices listed?

FraiyaScan is listed in the EU’s eudamed database, which is the official registry for medical devices within the European Union. This registration ensures transparency and compliance with EU medical device regulations.

How are Fraiya Ltd’s devices classified under medical device regulations?

FraiyaScan is classified as a Class IIa medical device. This classification is determined by its intended purpose, risk level, and the potential impact on patient safety. Class IIa devices require compliance with specific EU regulations but do not pose the highest risk compared to higher-class devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United Kingdom (ex Northern Ireland)
Address
61, Bridge Street, Kington, United Kingdom (ex Northern Ireland)
Phone
+44(0)2078489587(from company website)
PRRC contact
Harry Hopkinson
EUDAMED SRN
UK-MF-000045978