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Nulife

by Mrk Healthcare Pvt. Ltd. EUDAMED

Active European Union

Ref UDRLE

Regulatory status

as of 27 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Male Incontinence Device (U-drain)
Model / Reference
UDRLE
Primary DI / UDI-DI
08905159000098, 08905159000104, 08905159000135
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

  • 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