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Pre‑trigger Solution

by Beijing North Institute of Biotechnology Co., LTD China EUDAMED

Ref NAModel 100 mL per bottle, 200 mL per bottle

EMDN W01029099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697545658YJFYA-1DF Basic UDI-DIDate20 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
100 mL per bottle, 200 mL per bottle, NA
Primary DI / UDI-DI
06975456580038
Basic UDI-DI
697545658YJFYA-1DF
EMDN Code
W01029099 Immunochemistry reagents - other
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000059013
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06975456580038|697545658YJFYA-1DF 61 fields · synced 24 Oct 2026