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611 - Ankle Fusion Nail

by Tornier SAS 8 variants

Ref MJU759Model 370038690063GXA

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, self-declared

Class I: no certifier involved

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 Number370038690063GXA Basic UDI-DI 03700386966040UDI-DIDate24 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Tornier SAS Class I Devices - Torque Limiters - Class I - Non-Sterile
Model / Reference
370038690063GXA, MJU759
Primary DI / UDI-DI
03700386966040
Basic UDI-DI
370038690063GXA
Direct Marketing DI
03700386966040
EMDN Code
L091099 Osteosynthesis instruments, reusable - other
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
FR-MF-000011808

Other devices from Tornier SAS

See all devices from Tornier SAS →

Properties

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