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NICO BrainPath Approach

by NICO Corporation 14 variants

Ref NN-2521

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081674402PP1FG Basic UDI-DI 00816744022716UDI-DIDate10 May 2024RegisteredStatusActive

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  • Withdrawn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
NN-2521
Primary DI / UDI-DI
00816744022716
Basic UDI-DI
081674402PP1FG
EMDN Code
Z12109099 Various neurology and neurosurgery instruments - other
Device Class
Class III
Medical Purpose
To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as Primary/Secondary brain tumors, Vascular abnormalities/malformations, Intraventricular tumors/cysts

Manufacturer details

EUDAMED SRN
US-PR-000035011

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Properties

  • Sterile