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RightSign

by HangZhou Biotest Biotech Co., Ltd. 2 variants

Ref IHIV-C42, IHBSG-C31, DMDR-MSC8X, SVD-C42

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 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/IVDD NumberB-IHIV-C42M4 Basic UDI-DI Date20 Mar 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
HIV 1.2.O Rapid Test Caseette(Whole Blood/Serum/Plasma)
HBsAg Rapid Test Cassette(Serum/Plasma)
Multi-drug Rapid Test Cassette(SalivaTracer)
Vitamin D Rapid Test Cassette
Model / Reference
IHIV-C42, IHBSG-C31, DMDR-MSC8X, SVD-C42
Primary DI / UDI-DI
D-IHIV-C42M4, D-IHBSG-C31AR, D-DMDR-MSC8XET, D-SVD-C4243
Basic UDI-DI
B-IHIV-C42M4, B-IHBSG-C31AR, B-DMDR-MSC8XET, B-SVD-C4243
EMDN Code
W0105090302, W0105090201, W0102160511, W0101060199
Device Class
Class IVD Annex II List A
Class IVD General
EU market of registration
Germany
Croatia

Manufacturer details

EUDAMED SRN
CN-MF-000008191
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from HangZhou Biotest Biotech Co., Ltd.

See all devices from HangZhou Biotest Biotech Co., Ltd. →

Properties

  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing

Other properties (8)

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