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EXCELSIUS3D 6161.2100

by Globus Medical, Inc.

Ref 6161.2100

EXCELSIUS3D 6161.2100 is a portable general-purpose fluoroscopic x-ray system (EU MDR Class IIb; FDA Class II) made by Globus Medical, Inc., registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 0193982IMAGINGUM) with CE/MDR certificate 1000315034 valid until 14 May 2029, cleared under FDA 510(k) K210912 on 12 Aug 2021 and listed in FDA GUDID since 26 Jun 2024 (UDI-DI 00193982184537), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

14 May 2029

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

510(k) K210912

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0193982IMAGINGUM Basic UDI-DI 00193982184537UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00193982184537 UDI-DI Date26 Jun 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK210912 Date12 Aug 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0193982IMAGINGUM registered 23 Jun 2026 Active· +1 more in the status table
  • FDA 510(k) K210912 decided 12 Aug 2021 Active
  • FDA GUDID UDI-DI 00193982184537 listed 26 Jun 2024 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000315034 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    10 Jun 2026
    Expires
    14 May 2029
    Reason
    Add device or group

Timeline

5 dated events

  1. Cleared FDA 510(k) K210912
  2. Listed FDA GUDID 00193982184537
  3. Certificate issued EUDAMED 1000315034
  4. Registered EUDAMED 0193982IMAGINGUM
  5. Certificate expires EUDAMED 1000315034

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  • Withdrawn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
EXCELSIUS3D
Generic name
Portable general-purpose fluoroscopic x-ray system, digital
Device name
Imaging System
Model / reference
6161.2100
Primary DI / UDI-DI
00193982184537
Basic UDI-DI
0193982IMAGINGUM
Direct marketing DI
00193982184537
510(k) Number
FDA product code
OWB, JAA, OXO
EMDN code
Z110310 Multifunctional systems for traditional radiology
GMDN term
Portable general-purpose fluoroscopic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1650
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Portable general-purpose fluoroscopic x-ray system, digital

Cleared under the same submission (K210912)

Similar devices in this category

Other devices filed under MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY.

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)