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CK-MB Rapid Test

by Zhejiang Anji Saianfu Biotechnology Co., Ltd. China EUDAMED

Ref 3050101, 3051301

EMDN W0102160701

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-69743840311624 Basic UDI-DIDate28 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
CK-MB Rapid Test
Myoglobin/CK‐MB/Troponin I Rapid Combo Test
Model / Reference
3050101, 3051301
Primary DI / UDI-DI
69743840311624, 69743840311860
Basic UDI-DI
B-69743840311624, B-69743840311860
EMDN Code
W0102160701, W0102160706
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
CN-MF-000045029
Authorised representative
Lotus NL B.V. NL-AR-000000121

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (2)

  • EUDAMED f067fba0-4ef0-4564-b0a2-a2d3b17528de 61 fields · synced 22 Oct 2026
  • EUDAMED f9814d28-2ae9-41c0-a161-2751b5dfde52 61 fields · synced 18 May 2026