Skip to content

iFlash-CenpB IgG

by Shenzhen Yhlo Biotech Co., Ltd. United States EUDAMED

Ref C86078G-S EMDN W0102100115

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number692591270257HQ Basic UDI-DIDate15 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
C86078G-S
Primary DI / UDI-DI
06925912721185
Basic UDI-DI
692591270257HQ
EMDN Code
W0102100115 Anti-centromere antibodies
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000001137
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Yhlo Biotech Co., Ltd.

See all devices from Shenzhen Yhlo Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED a7b4769c-3e9f-467a-ae98-dc678e47af92 61 fields · synced 24 Oct 2026