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PD-1 Detection Kit (Flow Cytometry)

by Qingdao Raisecare Biological Technology Co., Ltd. China EUDAMED

Ref 100 tests, 200 tests, 50 tests

EMDN W0103080699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972227432145 Basic UDI-DIDate7 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
PD-1 Detection Kit (Flow Cytometry)
Model / Reference
100 tests, 200 tests, 50 tests
Primary DI / UDI-DI
06972227432145, 06972227432152, 06972227432138
Basic UDI-DI
B-06972227432145, B-06972227432152, B-06972227432138
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (3)

  • EUDAMED c3c37a30-c34b-4487-9cb1-b7b38ba972af 61 fields · synced 22 Oct 2026
  • EUDAMED 06972227432152|B-06972227432152 61 fields · synced 19 May 2026
  • EUDAMED 06972227432138|B-06972227432138 61 fields · synced 19 May 2026