Certificate valid

Snapshot 2026-10-28 · Link to EUDAMED

Emorsan Gel (10 single-dose vials of 2.2 ml)

UDI-DI 08050046270082Basic UDI-DI 805004627DEPOFARMA009504R

Class IIb · MDR · DEPOFARMA S.P.A.

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Identification

Model: 1 tube of 30 ml + anal applicator; 10 single-dose vials of 2.2 ml each; Free sample - not for sale (1 tube of 10 ml + anal applicator); Free sample - not for sale (1 single-dose vial of 2.2 ml)
EMDN: M04040502
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

MDR 000128-A

EU quality management system · valid

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

Valid from 2026-07-16 · Expiry 2030-11-16

Scope not stated in certificate data.

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

Manufacturer

DEPOFARMA S.P.A.

SRN IT-MF-000027122

IT · Preganziol

manufacturer

Related UDI-DIs

Emorsan Gel (30 ml tube + 1 anal applicator) 08050046270075
Emorsan Gel (Free sample not for sale: 30 ml tube filled to 10 ml + 1 anal applicator) 08050046270259

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/emorsan-gel-10-single-dose-vials-of-2-2-ml-0082 · UDI page: /udi/08050046270082

All devices from DEPOFARMA S.P.A.

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