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Galena

by Mrk Healthcare Pvt. Ltd. India EUDAMED

Ref UDRLE

EMDN U070201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8905159UDRLBG Basic UDI-DIDate1 Aug 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Male Incontinence Device (U-drain)
Model / Reference
UDRLE
Primary DI / UDI-DI
08905159002986
Basic UDI-DI
8905159UDRLBG
EMDN Code
U070201 Sheath catheter for the treatment of incontinence
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
IN-MF-000019843
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Mrk Healthcare Pvt. Ltd.

See all devices from Mrk Healthcare Pvt. Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Contains Latex
Other properties (11)
  • Implantable: No
  • Reusable: 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 48217582-c885-40d4-931c-fa07f5f0e6f1 61 fields · synced 22 Oct 2026