Skip to content

Pylon Cardiac Control 1

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

Ref 08-0183 Control-High Level:5x1mL Control-Low Level :5x1mLModel Control-High Level:5x1mL Control-Low Level :5x1mL

EMDN W0102152004

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697648502CC1SB 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  • Withdrawn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European Union — CE/IVDR Withdrawn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 23 Oct 2026

Model / Reference
Control-High Level:5x1mL Control-Low Level :5x1mL, 08-0183 Control-High Level:5x1mL Control-Low Level :5x1mL
Primary DI / UDI-DI
06976485023138
Basic UDI-DI
697648502CC1SB
Direct Marketing DI
06976485023138
EMDN Code
W0102152004 Cardiac marker controls
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.

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

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 c8488690-bd35-4b77-9715-0794187a5798 61 fields · synced 23 Oct 2026