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Rapid Strep A Ag Test

by Shenzhen Huian Biosci Technology Co., Ltd. EUDAMED

Active European Union

Ref 246-001Model 1T/Kit

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974831194006 Basic UDI-DIDate19 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Rapid Strep A Ag Test
Model / Reference
1T/Kit, 246-001
Primary DI / UDI-DI
06974831194006
Basic UDI-DI
B-06974831194006
EMDN Code
W0105011101 Streptococcal direct antigen detection
Device Class
Class IVD General
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000028080
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Shenzhen Huian Biosci Technology Co., Ltd.

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Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No