ALMA s.r.l.

Certificate EPT 0477.MDR.24/5636.3

Rev. Rev03Reissued

Valid until: Sep 22, 2029

Certificate EPT 0477.MDR.24/5636.3 is a valid Quality management system issued to ALMA s.r.l. and registered in EUDAMED. Valid until September 22, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: EPT 0477.MDR.24/5636.3
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0477EPT 0477.MDR.24/5636.3Rev03

Validity

Issued: Nov 5, 2025
Valid from: Nov 5, 2025
Valid until: Sep 22, 2029

Manufacturer

Manufacturer: ALMA s.r.l.
Manufacturer SRN: IT-MF-000029690
Manufacturer country: Italy

Notified body

Notified body
Notified body SRN: 0477
Notified body country: Italy

Covered devices

GYNO BALANCE Class IIb
805330089TD02BALAAJ

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

Supersedes

EPT 0477.MDR.24/5636.2ReissuedMay 14, 2025 → Sep 22, 2029
EPT 0477.MDR.24/5636.1ReissuedDec 20, 2024 → Sep 22, 2029
EPT 0477.MDR.24/5636IssuedOct 31, 2024 → Aug 22, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb1

1 scope

DEVICE
Class IIb

Documents

LanguagesENIT