GymnaUniphy N.V.

Certificate 2257802CE01

Rev. 2Supplemented

Valid until: Oct 1, 2028

Certificate 2257802CE01 is a valid Quality management system issued to GymnaUniphy N.V. and registered in EUDAMED. Valid until October 1, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 2257802CE01
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03442257802CE012

Validity

Issued: May 22, 2025
Valid from: May 22, 2025
Valid until: Oct 1, 2028

Manufacturer

Manufacturer: GymnaUniphy N.V.
Manufacturer SRN: BE-MF-000001786
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

Supplemented

Supersedes

2257802CE01SupplementedJan 19, 2024 → Oct 1, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa3

3 scopes

DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN