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Emorsan Rag (2 x 30 ml tubes + 2 anal applicators)

by Depofarma S.P.A. EUDAMED

Active European Union

Ref 1DEP02100Model 2 tubes of 30 ml + 2 anal applicators; Free sample - not for sale (1 tube of 10 ml + anal applicator)

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 000128-A Date16 Jul 2026IssuedStatusActive expires 16 Nov 2030

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 000128-A Issued

    Quality management system EU MDR

    Notified body
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    16 Jul 2026
    Expires
    16 Nov 2030

Specification

EUDAMED

Device Name
Gel-based medical devices for the protection of the anal mucosa
Model / Reference
2 tubes of 30 ml + 2 anal applicators, Free sample - not for sale (1 tube of 10 ml + anal applicator), 1DEP02100
Primary DI / UDI-DI
08050046270198
Basic UDI-DI
805004627DEPOFARMA021003G
EMDN Code
M04040502 Hydrogel dressings, combined with other substances
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027122

From the manufacturer

Manufacturer's product page: Ragadi anali

Other devices from Depofarma S.P.A.

See all devices from Depofarma S.P.A. →

Properties

Show properties
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No