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Promedon

by Promedon S.A. Argentina EUDAMED

Ref KIT-T-01

EMDN U070101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07798121800014 Basic UDI-DIDate30 Jun 2023RegisteredStatusActive

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 22 Oct 2026

Device Name
Safyre T
Model / Reference
KIT-T-01
Primary DI / UDI-DI
07798121800014
Basic UDI-DI
B-07798121800014
EMDN Code
U070101 Sling systems for the treatment of incontinence
Device Class
Class III
Market of Registration
Germany

Manufacturer details

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

Other devices from Promedon S.A.

See all devices from Promedon S.A. →

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 3ac55ff9-cca6-496b-9fe5-55bcfc922114 61 fields · synced 22 Oct 2026