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Automatic Registration, 2.5

by Brainlab SE

Ref 04056481142414

Automatic Registration, 2.5 (04056481142414) is a device classified as Class IIb in the EU and Class II in the US made by Brainlab SE, registered in EUDAMED on 1 Jul 2025 (Basic UDI-DI B-04056481142414), cleared under FDA 510(k) K203679 on 18 Mar 2021 (1 earlier submission) and listed in FDA GUDID since 20 Jan 2021 (UDI-DI 04056481142414), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K203679

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04056481142414 Basic UDI-DI 04056481142414UDI-DIDate1 Jul 2025RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK203679 Date18 Mar 2021DecidedStatusActive
United StatesGUDID listing GUDID Number04056481142414 UDI-DI Date20 Jan 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04056481142414 registered 1 Jul 2025 Active
  • FDA 510(k) K203679 decided 18 Mar 2021 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04056481142414 listed 20 Jan 2021 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K192703
  2. Listed FDA GUDID 04056481142414
  3. Cleared FDA 510(k) K203679
  4. Registered EUDAMED B-04056481142414

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Automatic Registration, 2.5 EUDAMED
Automatic Registration GUDID
Generic name
Robotic surgical navigation system
Model / reference
04056481142414 EUDAMED
2.5 GUDID
Primary DI / UDI-DI
04056481142414
Basic UDI-DI
B-04056481142414
510(k) Number
FDA product code
OLO, HAW
EMDN code
Z12011482 Surgical navigation instruments - software accessories
GMDN term
Robotic surgical navigation system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
04056481142414
GUDID
2.5
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
DE-MF-000006183

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - SOFTWARE ACCESSORIES.

Other devices from Brainlab SE

See all devices from Brainlab SE →

Properties

  • Lot / batch number
  • Serial number
Other properties (21, all answered No)