Skip to content

Opera Swing X-Ray R&F Remote System Opera Swing

by General Medical Merate SpA

Part of a family of 7 devices: see the family page

Ref OPERA SWINGModel RF rooms

Opera Swing X-Ray R&F Remote System Opera Swing is a medical device (EU MDR Class IIb; FDA Class II; FDA product code JAA, System, X-Ray, Fluoroscopic, Image-Intensified; EMDN category fluoroscopy devices) made by General Medical Merate SpA, registered in EUDAMED on 26 Jun 2026 (Basic UDI-DI 805489048SRFRD), cleared under FDA 510(k) K140380 on 26 Sep 2014 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 08054890480000), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140380

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805489048SRFRD Basic UDI-DI 08054890480000UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08054890480000 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK140380 Date26 Sep 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805489048SRFRD registered 26 Jun 2026 Active
  • FDA 510(k) K140380 decided 26 Sep 2014 Active
  • FDA GUDID UDI-DI 08054890480000 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140380
  2. Listed FDA GUDID 08054890480000
  3. Registered EUDAMED 805489048SRFRD

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  • Withdrawn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
Opera Swing
Generic name
Stationary general-purpose fluoroscopic x-ray system, digital
Device name
RF rooms
Model / reference
RF rooms EUDAMED
OPERA SWING EUDAMED
X-RAY R&F REMOTE SYSTEM OPERA SWING GUDID
Primary DI / UDI-DI
08054890480000
Basic UDI-DI
805489048SRFRD
510(k) Number
FDA product code
JAA
EMDN code
Z11039009 Fluoroscopy devices
GMDN term
Stationary general-purpose fluoroscopic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1650
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Weight — 1120 Kilogram

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
RF rooms
OPERA SWING
GUDID
X-RAY R&F REMOTE SYSTEM OPERA SWING
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: Stationary general-purpose fluoroscopic x-ray system, digital

Cleared under the same submission (K140380)

Similar devices in this category

Other devices filed under FLUOROSCOPY DEVICES.

Other devices from General Medical Merate SpA

See all devices from General Medical Merate SpA →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)