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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

Direxol

UDI-DI 08436593831271Basic UDI-DI 843659383XIA623N6

Class III · MDR · Noventure S.L.U.

Identification
Model
XILAPLUS AF capsules
EMDN
G0401
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

MDR 00064-B

EU technical documentation assessment · valid

Notified body: KIWA CERMET ITALIA S.P.A. (0476)

Valid from 2025-03-27 · Expiry 2029-11-14

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

MDR 00064-A

EU quality management system · valid

Notified body: KIWA CERMET ITALIA S.P.A. (0476)

Valid from 2025-03-27 · Expiry 2029-11-14

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Noventure S.L.U.

SRN ES-MF-000000797

ES · BARCELONA

manufacturer

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/direxol-1271 · UDI page: /udi/08436593831271

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