Skip to content

Novel Coronavirus (2019-nCoV) Antigen Rapid Test

by Tianjin Bioscience Diagnostic Technology Co., Ltd. 3 variants

Ref H201.03.00180.001, H201.03.00171.001, H201.03.00172.001Model 5 tests/ 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-06973914383092 Basic UDI-DI Date20 Jul 2022RegisteredStatusActive

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  • Withdrawn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
Novel Coronavirus (2019-nCoV) Antigen Rapid Test
Model / Reference
5 tests/ kit, H201.03.00180.001, H201.03.00171.001, H201.03.00172.001
Primary DI / UDI-DI
06973914383092, 06973914383108, D-06973914383078X5
Basic UDI-DI
B-06973914383092, B-06973914383108, B-06973914383078X5
EMDN Code
W01021699 Rapid tests & point of care - immunochemistry - other
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000023301
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Tianjin Bioscience Diagnostic Technology Co., Ltd.

See all devices from Tianjin Bioscience Diagnostic Technology Co., Ltd. →

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