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HCV Rapid Test

by Hangzhou Alltest Biotech.Co., Ltd.

Ref IHC-402

HCV Rapid Test (IHC-402) is a device classified as IVD Annex II List A made by Hangzhou Alltest Biotech.Co., Ltd., registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-06936983122894), active as of 7 Nov 2026.

Active European Union

CE IVDD

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936983122894 Basic UDI-DI Date30 Sep 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / reference
IHC-402
Primary DI / UDI-DI
06936983122894, 06936983126083, D-06936983106009W4, 06970277516587, 06936983106009, 06970277515047
Basic UDI-DI
B-06936983122894, B-06936983126083, B-06936983106009W4, B-06970277516587, B-06936983106009, B-06970277515047
EMDN code
W0105020303, W0105090202
Device class
Class IVD Annex II List A
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000010710
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Similar devices in this category

Other devices filed under HEPATITIS C VIRUS.

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Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (9, all answered No)