Skip to content

Bioptimal Thermodilution Catheter and Kits

by Bioptimal International PTE. LTD. 38 variants

Ref 24-000209-03Model BIOTRAY TD2755ND

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08886483504851 Basic UDI-DI 08886483504851UDI-DIDate28 Aug 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Thermodilution Catheter and Kits
Model / Reference
BIOTRAY TD2755ND, 24-000209-03
Primary DI / UDI-DI
08886483504851
Basic UDI-DI
B-08886483504851
EMDN Code
C019003 Thermodilution catheters
Device Class
Class III
EU market of registration
Germany

Manufacturer details

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

Other devices from Bioptimal International Pte. Ltd.

See all devices from Bioptimal International Pte. Ltd. →

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