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Pregnancy testing kit

by Nantong Diagnos Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref AE62Model Midstream（2 tests/box）

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06934592100067 Basic UDI-DIDate15 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
Midstream（2 tests/box）, AE62
Primary DI / UDI-DI
06934592100067
Basic UDI-DI
B-06934592100067
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000041526
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Nantong Diagnos Biotechnology Co., Ltd.

See all devices from Nantong Diagnos Biotechnology Co., Ltd. →

Properties

  • Reagent
  • Self Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No