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Respiratory Syncytial Virus（RSV）Rapid Test Kit（Colloidal Gold）

by WWHS Biotech.Inc

Ref CP109.B1Model 25Tests/kit

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-06975068491074 Basic UDI-DI 06975068491074UDI-DIDate11 Aug 2026RegisteredStatusActive

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  • Withdrawn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
Respiratory Syncytial Virus（RSV）Rapid Test Kit（Colloidal Gold）
Model / Reference
25Tests/kit, CP109.B1
Primary DI / UDI-DI
06975068491074
Basic UDI-DI
B-06975068491074
EMDN Code
W0105040605 Respiratory syncytial virus (rsv)
Device Class
Class IVD General
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000027179
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

  • Microbial Substances
  • Reagent
  • Professional Testing
  • Companion Diagnostics

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No