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Pylon Diluent 66

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

Ref 22-0056 Model 2 bottles (30 mL/bottle)/ kit

EMDN W0102010114

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697648502D66RN Basic UDI-DIDate13 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  • Withdrawn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European Union — CE/IVDR Withdrawn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 22 Oct 2026

Model / Reference
2 bottles (30 mL/bottle)/ kit, 22-0056
Primary DI / UDI-DI
06976485022575
Basic UDI-DI
697648502D66RN
Direct Marketing DI
06976485022575
EMDN Code
W0102010114 Buffers (unassignable), supplem. reagents, etc (ig's)
Device Class
Class A

Manufacturer details

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

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 351f1748-522c-45f4-b1c2-2064f34f50e5 61 fields · synced 22 Oct 2026