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Pylon FDP

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

Ref 20-2107 100 tests/kitModel 40 tests/kit 100 tests/kit 200 tests/kit

EMDN W0103020502

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697648502FDPUR Basic UDI-DIDate18 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  • Withdrawn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European Union — CE/IVDR Withdrawn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, 20-2107 100 tests/kit
Primary DI / UDI-DI
06976485022674
Basic UDI-DI
697648502FDPUR
Direct Marketing DI
06976485022674
EMDN Code
W0103020502 Fibrinogen degradation products
Device Class
Class C

Manufacturer details

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

Other 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 0b0620e9-a45e-46f7-9477-c863197f9bac 61 fields · synced 24 Oct 2026