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Multi-channel ECG

by Shenzhen ECGMAC Medical Electronics Co., Ltd. EUDAMED

Active European Union

Ref EM-301B, EM-301A, EM-601A, EM-1201A, EM-601

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06958511500233 Basic UDI-DIDate27 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Multi-channel ECG
Model / Reference
EM-301B, EM-301A, EM-601A, EM-1201A, EM-601
Primary DI / UDI-DI
06958511500233, 06958511500226, 06958511500202, 06958511500219, 06958511500028
Market of Registration
Bulgaria
Spain
France
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000040172
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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