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ISE Reference Solution Serum Control

by Yhlo Biotech (Nanjing) Co., Ltd. China EUDAMED

Ref 4SC2

EMDN W0101050101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-4SC2GX Basic UDI-DIDate30 Jul 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
4SC2
Primary DI / UDI-DI
D-4SC2GX
Basic UDI-DI
B-4SC2GX
EMDN Code
W0101050101 Assayed multicomponent controls (cc)
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000050474
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Yhlo Biotech (Nanjing) Co., Ltd.

See all devices from Yhlo Biotech (Nanjing) Co., Ltd. →

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 (1)

  • EUDAMED D-4SC2GX|B-4SC2GX 61 fields · synced 24 Oct 2026