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Sinapi Chest Drain

by SINAPI Biomedical (Pty) Ltd South Africa EUDAMED

Ref XS50Model XL1000+

EMDN A060203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number60099003867SCDW5 Basic UDI-DIDate5 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
XL1000+, XS50
Primary DI / UDI-DI
06009900386706
Basic UDI-DI
60099003867SCDW5
EMDN Code
A060203 Pleural drainages with valve and kits
Device Class
Class I
Market of Registration
Austria

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 276d7ace-c2ef-454b-90de-6fd2015ec412 61 fields · synced 22 Oct 2026