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Intravenous Start Kit

by ITL Asia Pacific Sdn. Bhd. Malaysia EUDAMED

Ref 061PC09052A EMDN V0599

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-09555240403377 Basic UDI-DIDate24 Jul 2024RegisteredStatusWithdrawn No longer placed on the EU market
European UnionCE/MDD NumberB-09555240403377 Basic UDI-DIDate24 Jul 2024RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Intravenous Starter Kit
IV Start Kit
Model / Reference
061PC09052A
Primary DI / UDI-DI
09555240403377, 09555240406873
Basic UDI-DI
B-09555240403377, 955524040IVSPR
EMDN Code
V0599 Clinical procedures kits not included in other classes - other
Device Class
Class IIa
Class I
Medical Purpose
The procedure pack provides the necessary items, required to prepare the skin for an IV cannula insertion and fixation.

Manufacturer details

EUDAMED SRN
MY-MF-000001570
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Itl Asia Pacific Sdn. Bhd.

See all devices from Itl Asia Pacific Sdn. Bhd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED be4906b3-37f1-4ea3-aa84-8ce601948182 61 fields · synced 23 Oct 2026
  • EUDAMED 09555240406873|955524040IVSPR 61 fields · synced 6 Oct 2026