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by HangZhou Biotest Biotech Co., Ltd. China EUDAMED

Ref ICFRM-MC85Model Cassette

EMDN W0105090699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06934078070341 Basic UDI-DIDate15 Oct 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 25 Oct 2026

Device Name
COVID-19+Flu A&B+ RSV+ Mycoplasma Pneumoniae Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab)
Model / Reference
Cassette, ICFRM-MC85
Primary DI / UDI-DI
06934078070341
Basic UDI-DI
B-06934078070341
EMDN Code
W0105090699 Other multiple pathogens - rt & poc
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000008191
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from HangZhou Biotest Biotech Co., Ltd.

See all devices from HangZhou Biotest Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 06934078070341|B-06934078070341 61 fields · synced 25 Oct 2026