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Artron HIV Ab, HBsAg & HCV Ab (3H) Combo Test (Artron 3H Combo Test)

by Artron Laboratories Inc.

Ref A02-20-322P25Model Cassette

Active European Union

CE IVDR

Valid until

6 Aug 2029

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number62834756AL0220026A Basic UDI-DI 00628347561079UDI-DIDate24 Feb 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2024-IVDR/QS-008/B Active Supplemented

    Quality management system EU IVDR

    Certifier
    3EC International a.s. 2265
    Issued
    27 Jan 2026
    Expires
    6 Aug 2029
    Reason
    Change approved
  • 2024-IVDR/TD-008/B Active Supplemented

    Technical documentation EU IVDR

    Certifier
    3EC International a.s. 2265
    Issued
    27 Jan 2026
    Expires
    6 Aug 2029
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
HIV Ab, HBsAg & HCV Ab (3H) Combo Test (Artron 3H Combo Test)
Model / Reference
Cassette, A02-20-322P25
Primary DI / UDI-DI
00628347561079
Basic UDI-DI
62834756AL0220026A
EMDN Code
W0105090201, W0105090202, W0105090302
Device Class
Class D
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
CA-MF-000028974
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

From the manufacturer

Manufacturer's product page: Artron HCG Pregnancy Test

Other devices from Artron Laboratories Inc.

See all devices from Artron Laboratories Inc. →

Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (8)

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