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Buzz O.R. Compute

by Brainlab SE

Ref 17922

Buzz O.R. Compute (17922) is a Class I device made by Brainlab SE, registered in EUDAMED on 9 Jul 2026 (Basic UDI-DI 4056481O.R.SuiteF6) and listed in FDA GUDID since 9 Jul 2026 (UDI-DI 04056481147099), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4056481O.R.SuiteF6 Basic UDI-DI 04056481147099UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04056481147099 UDI-DI Date9 Jul 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4056481O.R.SuiteF6 registered 9 Jul 2026 Active
  • FDA GUDID UDI-DI 04056481147099 listed 9 Jul 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 4056481O.R.SuiteF6
  2. Listed FDA GUDID 04056481147099

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Medical image management system
Model / reference
17922
Primary DI / UDI-DI
04056481147099
Basic UDI-DI
4056481O.R.SuiteF6
FDA product code
LMD
EMDN code
Z11069080 Various digital bioimaging management instruments - hardware accessories
GMDN term
Medical image management system
Device class
Class I
Regulation number
892.2020
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
DE-MF-000006183

Similar devices in this category

Other devices filed under VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Brainlab SE

See all devices from Brainlab SE →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)