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Gel&Clot Activator, 3ml, PET

by Jiangxi Exquisite Technology Co., Ltd. EUDAMED

Active European Union

Ref P01GC003, P01CA003Model 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  • Withdrawn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,3ml,PET
Clot Activator,3ml,PET
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, P01GC003, P01CA003
Primary DI / UDI-DI
06976560481648, 06976560481563
Basic UDI-DI
697656048BCT01KP
EMDN Code
W050101010201, W050101010202
Device Class
Class A
Market of Registration
Germany
Italy

Manufacturer details

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

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Properties

Show 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