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Ellavi UBT

by SINAPI Biomedical (Pty) Ltd South Africa EUDAMED

Ref UBT

EMDN U100102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number60099003902UBTUL Basic UDI-DIDate11 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
UBT
Primary DI / UDI-DI
06009900390239
Basic UDI-DI
60099003902UBTUL
EMDN Code
U100102 Postpartum intrauterine catheters
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ZA-MF-000012126
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from Sinapi Biomedical (Pty) Ltd

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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 3f28e4c6-af72-4421-a687-2a3e1693d49e 61 fields · synced 22 Oct 2026