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Lateral Flow (LF) Portable Reader Plus

by Hangzhou Alltest Biotech.Co., Ltd. 2 variants

Ref ATR-400Model Instrument

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, 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 Number6970277510019TZH Basic UDI-DI Date16 Oct 2024RegisteredStatusActive
European UnionCE/IVDR Number6970277510019TZH Basic UDI-DI Date16 Oct 2024RegisteredStatusActive

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  • Withdrawn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, CE/IVDR Active

Specification

EUDAMED

Model / Reference
Instrument, ATR-400
Primary DI / UDI-DI
06936983170222, 06936983131278, 06942598239308
Basic UDI-DI
6970277510019TZH, B-06936983131278
Direct Marketing DI
06936983170222
06942598239308
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class A
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 NoEUDAMEDYesEUDAMED
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No