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Clisis Systems

by General Medical Merate SpA

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

Ref CLISIS SYSTEMSModel RF rooms

Clisis Systems is a device classified as Class IIb in the EU and Class II in the US made by General Medical Merate SpA, registered in EUDAMED on 26 Jun 2026 (Basic UDI-DI 805489048SRFRD), cleared under FDA 510(k) K213081 on 26 Oct 2021 and listed in FDA GUDID since 11 Jul 2018 (UDI-DI 08054890480055), 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) K213081

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 08054890480055UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213081 Date26 Oct 2021DecidedStatusActive
United StatesGUDID listing GUDID Number08054890480055 UDI-DI Date11 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805489048SRFRD registered 26 Jun 2026 Active
  • FDA 510(k) K213081 decided 26 Oct 2021 Active
  • FDA GUDID UDI-DI 08054890480055 listed 11 Jul 2018 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 08054890480055
  2. Cleared FDA 510(k) K213081
  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  • Withdrawn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

Generic name
Stationary general-purpose fluoroscopic x-ray system, digital
Device name
RF rooms
Model / reference
CLISIS SYSTEMS, RF rooms
Primary DI / UDI-DI
08054890480055
Basic UDI-DI
805489048SRFRD
510(k) Number
FDA product code
KXJ, MQB, IZI, JAA, IZF
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
892.1980, 892.1680, 892.1600, 892.1650, 892.1740
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

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: Stationary general-purpose fluoroscopic x-ray system, digital

Cleared under the same submission (K213081)

and 6 more cleared under K213081

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)