Skip to content

H&W Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)

by Jiangsu Medomics Medical Technology Co., Ltd.

Ref HW-8combo-2026-01Model 123145-01-102 123145-02-102 123145-05-102 123145-20-102

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/IVDR Number697416789123145ZT Basic UDI-DI 06974167892393UDI-DIDate14 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)
Model / Reference
123145-01-102 123145-02-102 123145-05-102 123145-20-102, HW-8combo-2026-01
Primary DI / UDI-DI
06974167892393
Basic UDI-DI
697416789123145ZT
Direct Marketing DI
06974167892393
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class C
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
CN-MF-000030226
Authorised representative
Mega Eurostar Sp. z o.o. PL-AR-000042730

Other devices from Jiangsu Medomics Medical Technology Co., Ltd.

See all devices from Jiangsu Medomics Medical Technology Co., Ltd. →

Properties

  • Self Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No