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HLA B57 Real Time PCR Kit

by Snp Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Ve Üreti̇m Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇li̇mi̇ted EUDAMED

Active European Union

Ref 505R-10-01

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08680422281427 Basic UDI-DIDate15 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
505R-10-01
Primary DI / UDI-DI
08680422281427
Basic UDI-DI
B-08680422281427
EMDN Code
W0106010199 Monogenetic disorders tests - other
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000036548

From the manufacturer

Manufacturer's product page: Mutasyon Real-Time PCR Kitleri

Other devices from Snp Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Ve Üreti̇m Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇li̇mi̇ted

See all devices from Snp Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Ve Üreti̇m Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇li̇mi̇ted →

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