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Boiron Test & Care

by Suny (Xiamen) Biotechnology Co., Ltd. China EUDAMED

Ref F6061701 EMDN W0105090601

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06973861680404 Basic UDI-DIDate23 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  • Withdrawn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 · synced 24 Oct 2026

Device Name
Rapid SARS-CoV-2&Flu A&Flu B Antigen Test (Colloidal Gold)/ Nasal Swab
Model / Reference
F6061701
Primary DI / UDI-DI
06973861680404
Basic UDI-DI
B-06973861680404
EMDN Code
W0105090601 Coronavirus / influenza - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000035201
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Suny (Xiamen) Biotechnology Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Self Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 11a9eb2b-ac4d-46a0-9e57-fd6eb505bad1 61 fields · synced 24 Oct 2026