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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Noventure S.L.U.

Certificate MDR 00064-A

Rev. 2Issued
Valid until
Nov 14, 2029

Certificate MDR 00064-A is a valid Quality management system issued to Noventure S.L.U. and registered in EUDAMED. Valid until November 14, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number
MDR 00064-A
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0476MDR 00064-A2

Validity

Issued
Mar 27, 2025
Valid from
Mar 27, 2025
Valid until
Nov 14, 2029

Notified body

Notified body
KIWA CERMET ITALIA S.P.A.
Notified body SRN
0476
Notified body country
Italy

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
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III8

8 scopes

  • G0401 - Dispositivi a somministrazione orale per la terapia dei disturbi gastro-intestinali / Orally administered devices for the therapy of gastro-intestinal disorders
    Class III
  • G0499 - Dispositivi per apparato gastro-intestinale a somministrazione orale - altri / Orally administered gastrointestinal devices - other
    Class III
  • DEVICE
    Class III
  • DEVICE
    Class III
  • DEVICE
    Class III
  • DEVICE
    Class III
  • DEVICE
    Class III
  • DEVICE
    Class III

Manufacturer

Manufacturer
Noventure S.L.U.
Manufacturer SRN
ES-MF-000000797
Manufacturer country
Spain

Covered devices

  • XILAPLUS AF capsulesClass III
    843659383XIA623N6
  • XILAPLUS AF sachets without flavourClass III
    843659383XIA643NC
  • UTIPRO PLUS AF capsulesClass III
    843659383UTA423QE
  • Xilaplus AF sachets with flavourClass III
    843659383XIA633N9
  • Xilaplus AF tabletsClass III
    843659383XIA653NF
  • Utipro Plus AF tabletsClass III
    843659383UTA433QH

Documents

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