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Intramedullary Nail System

by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. 977 variants

Ref 15409393Model SGM-I

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697035671SGM-ILF Basic UDI-DI 06970356717867UDI-DIDate5 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
SGM-I, 15409393
Primary DI / UDI-DI
06970356717867
Basic UDI-DI
697035671SGM-ILF
EMDN Code
P09120201 Intramedullary nails
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

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

Related devices

Category: Arthrodesis intramedullary nail, non-distracting

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

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Properties

  • 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