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KL-6/SP-A/SP-D/MMP-7/CCL18 Detection Kit (Flow Cytometry)

by Qingdao Raisecare Biological Technology Co., Ltd. EUDAMED

Active European Union

Ref 50 tests, 200 tests, 100 tests

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972227432411 Basic UDI-DIDate7 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
KL-6/SP-A/SP-D/MMP-7/CCL18 Detection Kit (Flow Cytometry)
Model / Reference
50 tests, 200 tests, 100 tests
Primary DI / UDI-DI
06972227432411, 06972227432435, 06972227432428
Basic UDI-DI
B-06972227432411, B-06972227432435, B-06972227432428
EMDN Code
W0103080699 Reagents for flow cytometry - other
Device Class
Class IVD General
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000033899
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No