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Myoglobin Rapid Quantitative Test (Chemiluminescence Immunoassay)

by Xiamen BioRay Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref HR0509002

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977194141977 Basic UDI-DIDate25 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Myoglobin Rapid Quantitative Test (Chemiluminescence Immunoassay)
Model / Reference
HR0509002
Primary DI / UDI-DI
06977194141977
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000045502
Authorised representative
Medunion S.L. ES-AR-000019366

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