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Certificate SCAR-6.2.1.3 — Flok Health Ltd

MD Atlas
Documents

Flok Health Ltd

Certificate SCAR-6.2.1.3

Amended

Valid until: Aug 6, 2030

Certificate SCAR-6.2.1.3 is a valid Quality management system issued to Flok Health Ltd and registered in EUDAMED. Valid until August 6, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: SCAR-6.2.1.3
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 3022SCAR-6.2.1.3

Validity

Issued: Jun 10, 2026
Valid from: Jun 10, 2026
Valid until: Aug 6, 2030

Notified body

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

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: No
Intended medical purpose: No
SPP applicable

History

Status changes

Amended

Supersedes

SCAR-6.2.1.2Quality management systemAmendedMay 26, 2026 → Aug 6, 2030

Scope coverage

Class IIa2

2 scopes

MDA 0315 - Software
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN

No

Conditions applicable

No

MOS outside EUDAMED

No

QMS/MOS type

Basic UDI-DI data only

Scarlet NB B.V.

Manufacturer

Manufacturer: Flok Health Ltd
Manufacturer SRN: UK-MF-000047133
Manufacturer country: United Kingdom

Covered devices

50700023683CELBP1HYClass IIa
50700023683CELBP1HY