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Intramedullary Nail System

by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. China EUDAMED

Ref 15803620Model SWX-I EMDN P09120201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697035671SWX-IRN Basic UDI-DIDate5 Jun 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  • Withdrawn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 25 Oct 2026

Model / Reference
SWX-I, 15803620
Primary DI / UDI-DI
06931712405217
Basic UDI-DI
697035671SWX-IRN
EMDN Code
P09120201 Intramedullary nails
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000043758
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • Implantable
  • Sutures
Other properties (12)
  • Sterile: 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 06931712405217|697035671SWX-IRN 61 fields · synced 25 Oct 2026