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A1 Gel

by Red Cell Bi̇yoteknoloji̇ A.Ş. Türkiye EUDAMED

Ref RCA1

EMDN W0103030399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08682484709772 Basic UDI-DIDate21 May 2026RegisteredStatusActive

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 24 Oct 2026

Model / Reference
RCA1
Primary DI / UDI-DI
08682484709772, 08682484709055
Basic UDI-DI
B-08682484709772, B-08682484709055
EMDN Code
W0103030399 Antibody detection (immunohaematology) - other
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000026921

Other devices from Red Cell Bi̇yoteknoloji̇ A.Ş.

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Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (2)

  • EUDAMED 2834d5ab-01c0-457e-86b0-82dbd9deb0f7 61 fields · synced 24 Oct 2026
  • EUDAMED 08682484709055|B-08682484709055 61 fields · synced 17 Jul 2026