Skip to content

NaoTrac

by Brain Navi Biotechnology Co., Ltd.

Ref FPNT0101Model NaoTrac

NaoTrac (FPNT0101) is a medical device (EU MDD Class IIb) made by Brain Navi Biotechnology Co., Ltd., registered in EUDAMED on 10 Feb 2022 (Basic UDI-DI B-04719878690010), active as of 22 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04719878690010 Basic UDI-DI Date10 Feb 2022RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Surgical Navigation Robot
Stereotaxic Guiding Surgical Devices
Model / reference
NaoTrac, FPNT0101
Primary DI / UDI-DI
04719878690010, 04719878691000
Basic UDI-DI
B-04719878690010, B-04719878691000
EMDN code
Z12011401, Z12100601
Device class
Class IIb
System or procedure pack
System which is a device in itself
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

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

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION SYSTEM.

Other devices from Brain Navi Biotechnology Co., Ltd.

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

Properties

Other properties (12, all answered No)