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Gel&Clot Activator, 8ml

by Jiangxi Exquisite Technology Co., Ltd. EUDAMED

Active European Union

Ref P05GC005, B05GC008, B05CA008, B05K2008, B05K3008Model Plain tube (No Additive), EDTA.K2, EDTA.K2/Gel, EDTA.K3, EDTA.Na2, Sodium Citrate 9NC, Sodium Citrate 9NC /Gel, Sodium Citrate 4NC, etc

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  • Withdrawn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

Trade Name
Gel&Clot Activator,8ml
Clot Activator,8ml
EDTA.K2,8ml
EDTA.K3,8ml
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, P05GC005, B05GC008, B05CA008, B05K2008, B05K3008
Primary DI / UDI-DI
06976560481143, 06976560480689, 06976560480672, 06976560480702, 06976560480719
Basic UDI-DI
697656048BCT01KP
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class A
Market of Registration
Croatia
Austria
Spain
Italy
Romania

Manufacturer details

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

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Properties

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