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RevoDx Staphyloccocus spp. qPCR Kit

by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. Türkiye EUDAMED

Ref IP202209-500, IP202209-100 EMDN W0105011102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08684387213264 Basic UDI-DIDate4 May 2026RegisteredStatusActive

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  • Withdrawn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 · synced 22 Oct 2026

Model / Reference
IP202209-500, IP202209-100
Primary DI / UDI-DI
08684387213264, 08683079717509
Basic UDI-DI
B-08684387213264, B-08683079717509
EMDN Code
W0105011102 Streptococcal detection by na reagents
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000047330

Other devices from İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.

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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 (2)

  • EUDAMED c5fb9d76-e1f5-4ede-b420-114ae9fc36b9 61 fields · synced 22 Oct 2026
  • EUDAMED 08683079717509|B-08683079717509 61 fields · synced 18 May 2026