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Bioptimal Thermodilution Catheter and Kits

by Bioptimal International PTE. LTD. EUDAMED

Active European Union

Ref 24-000201-16Model BIOTRAY TD2704N

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08886483511422 Basic UDI-DIDate29 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Thermodilution Catheter and Kits
Model / Reference
BIOTRAY TD2704N, 24-000201-16
Primary DI / UDI-DI
08886483511422
Basic UDI-DI
B-08886483511422
EMDN Code
C019003 Thermodilution catheters
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
SG-MF-000010306
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Sterile
  • Contains Latex
  • Administering Medicine

Other properties (8)

  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No