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Columbus™ External Reference Patch

by Shanghai MicroPort EP MedTech Co., Ltd. FDA registration: China EUDAMED

Ref EPTR150BModel EPTR150A EMDN C020199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69524509C6E10G3 Basic UDI-DIDate1 Apr 2024RegisteredStatusActive

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  • Withdrawn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
Columbus External Reference Patch
Model / Reference
EPTR150A, EPTR150B
Primary DI / UDI-DI
06952450982501
Basic UDI-DI
69524509C6E10G3
EMDN Code
C020199 Cardiac electrophysiology and mapping devices - other
Device Class
Class I
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000008518
Authorised representative
MicroPort Medical B.V. NL-AR-000000166

Other devices from Shanghai Microport Ep Medtech Co., Ltd.

See all devices from Shanghai Microport Ep Medtech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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 4a1d5537-a0d3-4f27-8ecb-90fd1baccc6f 61 fields · synced 24 Oct 2026