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Guide Catheter

by Changzhou Lunghealth Medtech Co, . Ltd. China EUDAMED

Ref EMNC002-G26OP00Model EMNC002

EMDN Z12011485

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6975102676975102670137WA Basic UDI-DIDate17 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Guide Catheter
Model / Reference
EMNC002, EMNC002-G26OP00
Primary DI / UDI-DI
06975102670007
Basic UDI-DI
6975102676975102670137WA
EMDN Code
Z12011485 Surgical navigation instruments - consumables
Device Class
Class IIa
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000024014
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Changzhou Lunghealth 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 afb116b0-f07b-4c70-ab29-3e8af7186c4f 61 fields · synced 22 Oct 2026