Flen Health Pharma

Certificate 2253359CE01

Rev. 2Amended

Valid until: Nov 1, 2027

Certificate 2253359CE01 is a valid Quality management system issued to Flen Health Pharma and registered in EUDAMED. Valid until November 1, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 2253359CE01
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03442253359CE012

Validity

Issued: Dec 8, 2025
Valid from: Dec 8, 2025
Valid until: Nov 1, 2027

Manufacturer

Manufacturer: Flen Health Pharma
Manufacturer SRN: BE-MF-000000258
Manufacturer country: Belgium

Notified body

Notified body
Notified body SRN: 0344
Notified body country: Netherlands

Covered devices

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Amended

Supersedes

857496CE01AmendedDec 16, 2022 → Nov 1, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb2

2 scopes

DEVICE
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN