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Pylon CK-MB

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

Active European Union EUDAMED: not on the EU market

Ref 10-2027 40 tests/kitModel 40 tests/kit 100 tests/kit 200 tests/kit

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697648502CKMBQ3 Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
40 tests/kit 100 tests/kit 200 tests/kit, 10-2027 40 tests/kit
Primary DI / UDI-DI
06976485022810
Basic UDI-DI
697648502CKMBQ3
Direct Marketing DI
06976485022810
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

  • 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