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Bioptimal Central Venous Catheter and Catheterization Kit

by Bioptimal International PTE. LTD. 42 variants

Ref 25-000011-66Model CVNR-701-16

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08886483505889 Basic UDI-DI 08886483505889UDI-DIDate14 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  • Withdrawn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
Central Venous Catheter and Catheterization Kit
Model / Reference
CVNR-701-16, 25-000011-66
Primary DI / UDI-DI
08886483505889
Basic UDI-DI
B-08886483505889
EMDN Code
C01020201 Central i.v. single-lumen catheters, non-tunneled
Device Class
Class III
EU market of registration
Greece

Manufacturer details

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

Related devices

Category: Central venous catheterization kit, short-term

Other devices from Bioptimal International Pte. Ltd.

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Properties

  • Sterile
  • Administering Medicine

Other properties (9)

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