Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

SANTES® Ovules vaginaux/vaginal pessaries

UDI-DI 08058481250065Basic UDI-DI 805848125SantesOvuliWF

Class IIb · MDR · LO.LI. PHARMA S.r.l.

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Identification

Model: Ovulo Vaginale / Vaginal Capsul
EMDN: U0899
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

EPT 0477.MDR.22/4914.2

EU quality management system · valid

Notified body: Eurofins Product Testing Italy S.r.l. (0477)

Valid from 2024-05-24 · Expiry 2027-08-03

Scope not stated in certificate data.

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

Manufacturer

LO.LI. PHARMA S.r.l.

SRN IT-MF-000023734

IT · Roma

manufacturer

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HYAVAGE Vajinal Ovul 08058481251260
IAGYNEL® Ovuli Vaginali 08058481250744
IAGYNEL® Ovuli Vaginali 08058481250768
PREMENO 08058481250782
PREMENO Ovules Vaginaux 08058481250966
PREMENO Ovules Vaginaux 08058481250973
PREMENO Vaginalzäpfchen 08058481250799
SANTES hüvelyikúp 08058481250096

Showing 12 of 18 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/santes-ovules-vaginaux-vaginal-pessaries-0065 · UDI page: /udi/08058481250065

All devices from LO.LI. PHARMA S.r.l.

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