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Prostate- Specific Antigen (PSA) Rapid Test

by Hangzhou Alltest Biotech.Co., Ltd. China EUDAMED

Ref TPS-NQ402HB-01 EMDN W0102160202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6970277510015EY7 Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EU-TDA-FI-51326-800081-2026 Issued

    Technical documentation EU IVDR

    Notified body
    Notified body 3018
    Issued
    23 Apr 2026
    Expires
    16 Apr 2031

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
TPS-NQ402HB-01
Primary DI / UDI-DI
06936983190749
Basic UDI-DI
6970277510015EY7
EMDN Code
W0102160202 Psa - rt & poc
Device Class
Class C
Market of Registration
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.

See all devices from Hangzhou Alltest Biotech.Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Self Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06936983190749|6970277510015EY7 61 fields · synced 25 Oct 2026