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Entamoeba+Giardia+Crypto Combo Rapid Test Cassette

by Hangzhou Alltest Biotech.Co., Ltd.

Ref IEGC-R635

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-IEGC-R6352S Basic UDI-DI Date13 Jul 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  • Withdrawn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
Entamoeba+Giardia+Crypto Combo Rapid Test
Model / Reference
IEGC-R635
Primary DI / UDI-DI
D-IEGC-R6352S, D-IEGC-R635(AT)RX
Basic UDI-DI
B-IEGC-R6352S, B-IEGC-R635(AT)RX
EMDN Code
W0105090499 Parasites - rt & poc - other
Device Class
Class IVD General
EU market of registration
Austria
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000010710
Authorised representative
VidaQuick Biotech S.L. ES-AR-000048138

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Properties

  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Professional Testing

Other properties (9)

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