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Pylon CK-MB

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

Ref 30-2027 200 tests/kitModel 40 tests/kit 100 tests/kit 200 tests/kit EMDN W01021311

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697648502CKMBQ3 Basic UDI-DIDate19 May 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
40 tests/kit 100 tests/kit 200 tests/kit, 30-2027 200 tests/kit
Primary DI / UDI-DI
06976485022834
Basic UDI-DI
697648502CKMBQ3
Direct Marketing DI
06976485022834
EMDN Code
W01021311 Creatine kinase - mb mass (ic)
Device Class
Class C

Manufacturer details

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

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 30a09986-f358-4364-a7c8-26d213ebcb5f 61 fields · synced 23 Oct 2026