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Hollister

by Hollister Incorporated United States EUDAMED

Ref 97136-15

EMDN U070201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number610075D01P030S00586W Basic UDI-DIDate1 Oct 2025RegisteredStatusActive

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
Male Incontinence Sheath (Catheter)
Model / Reference
97136-15
Primary DI / UDI-DI
00610075070688
Basic UDI-DI
610075D01P030S00586W
Unit of Use DI
20610075070682
EMDN Code
U070201 Sheath catheter for the treatment of incontinence
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000027818
Authorised representative
Hollister ULC IE-AR-000022119

Other devices from Hollister Incorporated

See all devices from Hollister Incorporated →

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 9be47b00-5909-46ae-a9a5-1a028c73a05f 61 fields · synced 23 Oct 2026