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ISE Reference Solution Urine Calibrator

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

Ref 4US300

EMDN W0101050301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-4US3008P 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
4US300
Primary DI / UDI-DI
D-4US3008P
Basic UDI-DI
B-4US3008P
EMDN Code
W0101050301 Calibrators multicomponent (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 29e55c9e-68e2-4a41-a093-4ea98b774c44 61 fields · synced 24 Oct 2026