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Entamoeba+Giardia+Crypto Combo Rapid Test Cassette (Feces)

by Hangzhou Alltest Biotech.Co., Ltd.

Ref IEGC-635

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, self-declared

Class I: no certifier involved

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/IVDD NumberB-06942598213919 Basic UDI-DI Date18 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Trade Name
Entamoeba+Giardia+Crypto Combo Rapid Test Cassette (Feces)
Entamoeba+Giardia+Crypto Combo Rapid Test Cassette
Model / Reference
IEGC-635
Primary DI / UDI-DI
06942598213919, 06942598247976, D-IEGC-635AD
Basic UDI-DI
B-06942598213919, B-06942598247976, B-IEGC-635AD
EMDN Code
W0105050299, W0105090499
Device Class
Class IVD General
EU market of registration
Ireland
Austria

Manufacturer details

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

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Properties

  • Animal Tissues
  • Reagent YesEUDAMEDNoEUDAMED
  • 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