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Rotavirus and Adenovirus Combo Rapid Test

by Hangzhou Alltest Biotech.Co., Ltd.

Ref IRAC-N625J-25, IRAC-N625B-25, IRAC-625, IRAC-N625

Active European Union

CE IVDR 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number6970277510000DXH Basic UDI-DI Date29 Aug 2022RegisteredStatusActive
European UnionCE/IVDR Number6970277510000DXH Basic UDI-DI Date29 Aug 2022RegisteredStatusActive

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  • Withdrawn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, CE/IVDR Active

Specification

EUDAMED

Trade Name
Rotavirus and Adenovirus Combo Rapid Test
Rotavirus and Adenovirus Combo Rapid Test Cassette (Feces)
Model / Reference
IRAC-N625J-25, IRAC-N625B-25, IRAC-625, IRAC-N625
Primary DI / UDI-DI
06936983109550, 06936983109444, 06970277511117, 06936983104432, 06970277515580, 06942598206966
Basic UDI-DI
6970277510000DXH, B-06970277511117, B-06970277515580, B-06942598206966
EMDN Code
W0105040699, W0105070599
Device Class
Class B
Class IVD General
EU market of registration
Germany
Ireland

Manufacturer details

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

Other devices from Hangzhou Alltest Biotech.Co., Ltd.

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Properties

  • Animal Tissues
  • 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