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Promedon

by Promedon S.A. Argentina EUDAMED

Ref KIT-UT-01

EMDN P900202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07798121803558 Basic UDI-DIDate7 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Splentis
Model / Reference
KIT-UT-01
Primary DI / UDI-DI
07798121803558
Basic UDI-DI
B-07798121803558
EMDN Code
P900202 Polypropylene surgical meshes
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
AR-MF-000023348
Authorised representative
MDSS GmbH DE-AR-000005430

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 45d039b4-a9da-41fb-b85b-e55b571d5464 61 fields · synced 23 Oct 2026