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"Selbstklebende Kondome, SAUER-Comfort - Standard, Schlauchansatz, normaler Kleber, Ø 20 mm, Kondomlänge 130 mm, Pufferzone 75 mm, Klebezone 50 mm"

by Manfred Sauer GmbH Germany EUDAMED

Ref 97.20-2

EMDN U070201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42502745000001E8 Basic UDI-DIDate22 Jun 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Synthetische Urinal-Kondome
Model / Reference
97.20-2
Primary DI / UDI-DI
04250274545998
Basic UDI-DI
42502745000001E8
EMDN Code
U070201 Sheath catheter for the treatment of incontinence
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006287

Other devices from Manfred Sauer GmbH

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Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED e08cc07d-bb7b-4f60-805d-23e2917946b1 61 fields · synced 23 Oct 2026