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Sodium Heparin, 5ml

by Jiangxi Exquisite Technology Co., Ltd. China EUDAMED

Ref P01SH005/P02SH005, B01K3005/B02K3005, B01K2005/B02K2005, P01K2005/P02K2005, P01K3005/P01K3005Model Plain tube (No Additive), EDTA.K2, EDTA.K2/Gel, EDTA.K3, EDTA.Na2, Sodium Citrate 9NC, Sodium Citrate 9NC /Gel, Sodium Citrate 4NC, etc EMDN W050101010201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697656048BCT01KP Basic UDI-DIDate12 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Sodium Heparin,5ml
EDTA.K3,5ml
EDTA.K2,5ml
Device Name
Blood Collection Tube For Single-Use
Model / Reference
Plain tube (No Additive), EDTA.K2, EDTA.K2/Gel, EDTA.K3, EDTA.Na2, Sodium Citrate 9NC, Sodium Citrate 9NC /Gel, Sodium Citrate 4NC, etc, P01SH005/P02SH005, B01K3005/B02K3005, B01K2005/B02K2005, P01K2005/P02K2005, P01K3005/P01K3005
Primary DI / UDI-DI
06976560481433, 06976560480443, 06976560480436, 06976560481440, 06976560481396
Basic UDI-DI
697656048BCT01KP
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class A
Market of Registration
Romania
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000038653
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Jiangxi Exquisite Technology Co., Ltd.

See all devices from Jiangxi Exquisite Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (5)

  • EUDAMED daafe346-aded-4941-8af1-4f6ca68f2859 61 fields · synced 22 Oct 2026
  • EUDAMED 06976560480443|697656048BCT01KP 61 fields · synced 9 Jul 2026
  • EUDAMED 06976560480436|697656048BCT01KP 61 fields · synced 9 Jul 2026
  • EUDAMED 06976560481440|697656048BCT01KP 61 fields · synced 9 Jul 2026
  • EUDAMED 06976560481396|697656048BCT01KP 61 fields · synced 26 Jul 2026