DEVINTEC SAGL

Certificate IT325651

Rev. 6Supplemented

Valid until: Sep 7, 2028

Certificate IT325651 is a valid Quality management system issued to DEVINTEC SAGL and registered in EUDAMED. Valid until September 7, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: IT325651
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 6
Certificate ID: 1370IT3256516

Validity

Issued: Sep 26, 2025
Valid from: Sep 26, 2025
Valid until: Sep 7, 2028

Notified body

Notified body: BUREAU VERITAS ITALIA S.P.A.
Notified body SRN: 1370
Notified body country: Italy

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

IT325651Quality management systemSupplementedMar 18, 2025 → Sep 7, 2028

Scope coverage

Class III6

6 scopes

MDN 1213 - Dispositivi non impiantabili non attivi costituiti da sostanze destinate a essere introdotte nel corpo umano attraverso un orifizio del corpo o per via cutanea.
Class III
SECTACOL; LEFAXAN PROTECT; FYBOCALM WIND & BLOATING RELIEF;GAVIDIGEST FLATULENCES & BALLONNEMENTS
Class III
GELSELAX; FYBOCALM CONSTIPATION RELIEF;GAVIDIGEST CONSTIPATION RELIEF
Class III
GELSECTAN; GELSECTAN IBUTIN; FYBOCALM DIARRHOEA RELIEF;GAVIDIGEST DIARRHEE
Class III
GAVISCON INTESTINO GONFIORE E METEORISMO; GAVIDIGEST GASES E HINCHAZON; GAVIDIGEST GASES E INCHAÇO
Class III
GAVISCON INTESTINO STITICHEZZA; GAVIDIGEST ESTRENIMIENTO; GAVIDIGEST OBSTIPAÇÃO
Class III

Documents

LanguagesEN