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Navbit Rapid Surgical Plan

by Navbit Pty Ltd EUDAMED510(k)

Active United States and European Union

Ref RSP-SW-001

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number93623480RSPSW001GE Basic UDI-DIDate25 Feb 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK243447 Date5 Dec 2024IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR 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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · 510(k)

Model / Reference
RSP-SW-001
Primary DI / UDI-DI
09369900041935
Basic UDI-DI
93623480RSPSW001GE
Direct Marketing DI
09369900041935
EMDN Code
Z110603 Picture archiving and communication systems
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
AU-MF-000016920
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Navbit Pty Ltd

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No