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Brainlab Elements Contouring 4.5

by Brainlab SE

Ref 04056481144623

Brainlab Elements Contouring 4.5 is a device classified as Class IIb in the EU and Class II in the US made by Brainlab SE, registered in EUDAMED on 30 Jun 2025 (Basic UDI-DI 4056481ContouringZQ), cleared under FDA 510(k) K223106 on 14 Jul 2023 and listed in FDA GUDID since 20 Jul 2023 (UDI-DI 04056481144623), active as of 25 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223106

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4056481ContouringZQ Basic UDI-DI 04056481144623UDI-DIDate30 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04056481144623 UDI-DI Date20 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223106 Date14 Jul 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4056481ContouringZQ registered 30 Jun 2025 Active
  • FDA 510(k) K223106 decided 14 Jul 2023 Active
  • FDA GUDID UDI-DI 04056481144623 listed 20 Jul 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K223106
  2. Listed FDA GUDID 04056481144623
  3. Registered EUDAMED 4056481ContouringZQ

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Brainlab Elements Contouring, 4.5 EUDAMED
Brainlab Elements Contouring GUDID
Generic name
Stereotactic system application software
Model / reference
04056481144623 EUDAMED
4.5 GUDID
Primary DI / UDI-DI
04056481144623
Basic UDI-DI
4056481ContouringZQ
Direct marketing DI
04056481144623
510(k) Number
FDA product code
QIH, JAK, LLZ
EMDN code
Z11069092 Various digital bioimaging management instruments - medical device software
GMDN term
Stereotactic system application software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.2050, 892.1750
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
04056481144623
GUDID
4.5
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.

Related devices

Category: Stereotactic system application software

Similar devices in this category

Other devices filed under VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Brainlab SE

See all devices from Brainlab SE →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)