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Chlamydia Rapid Test Cassette

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

Ref ICH-502, ICH-N502FHB-05, ICH-N502FHB-01, ICH-N502FHJ-01, ICH-N502H-02, ICH-N502FHJ-02, ICH-N502MH-02, ICH-N502H-01, ICH-N502MH-05, ICH-N502FH-05, ICH-N502HB-01, ICH-N502HB-02, ICH-N502HJ-01, ICH-N502MHB-01

EMDN W0105010107

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberEU-TDA-FI-51326-800081-2026 Date23 Apr 2026IssuedStatusActive expires 16 Apr 2031
European UnionCE/IVDD NumberB-06970277511032 Basic UDI-DIDate8 Apr 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD 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 22 Oct 2026

Trade Name
Chlamydia Rapid Test Cassette
Chlamydia Rapid Test
Model / Reference
ICH-502, ICH-N502FHB-05, ICH-N502FHB-01, ICH-N502FHJ-01, ICH-N502H-02, ICH-N502FHJ-02, ICH-N502MH-02, ICH-N502H-01, ICH-N502MH-05, ICH-N502FH-05, ICH-N502HB-01, ICH-N502HB-02, ICH-N502HJ-01, ICH-N502MHB-01
Primary DI / UDI-DI
06970277511032, 06936983185868, 06936983185844, 06936983185936, 06936983185738, 06936983185943, 06936983185790, 06936983185721, 06936983185806, 06936983185776, 06936983185813, 06936983185820, 06936983185905, 06936983185875
Basic UDI-DI
B-06970277511032, 6970277510015CY3
EMDN Code
W0105010107, W0105090101
Device Class
Class IVD Annex II List B
Class C
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.

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

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues NoEUDAMEDYesEUDAMED
  • Microbial Substances YesEUDAMEDNoEUDAMED
  • Reagent
  • Self Testing NoEUDAMEDYesEUDAMED
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (14)

  • EUDAMED bab67131-e102-4e3c-a858-07bf595774b2 61 fields · synced 22 Oct 2026
  • EUDAMED 06936983185868|6970277510015CY3 61 fields · synced 10 Jul 2026
  • EUDAMED 06936983185844|6970277510015CY3 61 fields · synced 10 Jul 2026
  • EUDAMED 06936983185936|6970277510015CY3 61 fields · synced 11 Jul 2026
  • EUDAMED 06936983185738|6970277510015CY3 61 fields · synced 11 Jul 2026
  • EUDAMED 06936983185943|6970277510015CY3 61 fields · synced 12 Jul 2026
  • EUDAMED 06936983185790|6970277510015CY3 61 fields · synced 15 Jul 2026
  • EUDAMED 06936983185721|6970277510015CY3 61 fields · synced 15 Jul 2026
  • EUDAMED 06936983185806|6970277510015CY3 61 fields · synced 16 Jul 2026
  • EUDAMED 06936983185776|6970277510015CY3 61 fields · synced 20 Jul 2026
  • EUDAMED 06936983185813|6970277510015CY3 61 fields · synced 25 Jul 2026
  • EUDAMED 06936983185820|6970277510015CY3 61 fields · synced 25 Jul 2026
  • EUDAMED 06936983185905|6970277510015CY3 61 fields · synced 27 Jul 2026
  • EUDAMED 06936983185875|6970277510015CY3 61 fields · synced 18 Sep 2026