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FPSD0101

by Brain Navi Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref FPSD0101

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04719878692007 Basic UDI-DIDate12 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

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.

Specification

EUDAMED

Model / Reference
FPSD0101
Primary DI / UDI-DI
04719878692007
Basic UDI-DI
B-04719878692007
EMDN Code
Z12100601 Stereotactic neurosurgery systems
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000016990
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Brain Navi Biotechnology Co., Ltd.

See all devices from Brain Navi Biotechnology Co., Ltd. →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No