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PulseMagic Pulsed Field Ablation Generator

by Shanghai MedPulses MedTech Co., Ltd. China EUDAMED

Ref 06977275460782Model SYNE-PFA-1A, SYE-PFA-1A EMDN Z12059011

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697727546C6F23GN Basic UDI-DIDate14 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
PulseMagic Pulsed Field Ablation Generator
Model / Reference
SYNE-PFA-1A, SYE-PFA-1A, 06977275460782
Primary DI / UDI-DI
06977275460782
Basic UDI-DI
697727546C6F23GN
EMDN Code
Z12059011 Cardiac ablation equipment
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000043285
Authorised representative
MicroPort Medical B.V. NL-AR-000000166

Other devices from Shanghai MedPulses MedTech Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 92c43e5b-2029-48e9-b404-19633d55987b 61 fields · synced 24 Oct 2026