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Pylon β-HCG

by ET Healthcare (Suzhou) Co., Ltd. China EUDAMED

Ref 10-2117 40 tests/kitModel 40 tests/kit 100 tests/kit 200 tests/kit

EMDN W0102050206

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697648502HCGUE Basic UDI-DIDate14 May 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
40 tests/kit 100 tests/kit 200 tests/kit, 10-2117 40 tests/kit
Primary DI / UDI-DI
06976485022933
Basic UDI-DI
697648502HCGUE
Direct Marketing DI
06976485022933
EMDN Code
W0102050206 B- human chorionic gonadotropin (incl. subunit)
Device Class
Class B

Manufacturer details

EUDAMED SRN
CN-MF-000039448
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from ET Healthcare (Suzhou) Co., Ltd.

See all devices from ET Healthcare (Suzhou) Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 5edf3e21-59df-4d34-aad0-2881842e2736 61 fields · synced 24 Oct 2026