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Myo Rapid Quantitative Test (Fluorescence Immunoassay)

by Xiamen BioRay Biotechnology Co., Ltd.

Ref HR0201701

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977194141694 Basic UDI-DI 06977194141694UDI-DIDate25 Oct 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Myo Rapid Quantitative Test (Fluorescence Immunoassay)
Model / Reference
HR0201701
Primary DI / UDI-DI
06977194141694
Basic UDI-DI
B-06977194141694
EMDN Code
W0102160702 Myoglobin - rt & poc
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

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

Other devices from Xiamen BioRay Biotechnology Co., Ltd.

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Properties

  • Reagent
  • Professional Testing
  • Surgical Instrument

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No