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Orfit 18200/INDEX

by Orfit Industries NV

Part of a family of 28 devices: see the family page

Ref 18200/INDEXModel Vacuum Bag Cushions

Orfit 18200/INDEX is a device classified as Class I in the EU and Class II in the US made by Orfit Industries NV, registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI 5420028700314V), cleared under FDA 510(k) K991319 on 21 Sep 1999 and listed in FDA GUDID since 15 Apr 2026 (UDI-DI 05420028708484), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K991319

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5420028700314V Basic UDI-DI 05420028708484UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05420028708484 UDI-DI Date15 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK991319 Date21 Sep 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5420028700314V registered 17 Sep 2026 Active
  • FDA 510(k) K991319 decided 21 Sep 1999 Active
  • FDA GUDID UDI-DI 05420028708484 listed 15 Apr 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K991319
  2. Listed FDA GUDID 05420028708484
  3. Registered EUDAMED 5420028700314V

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  • Withdrawn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
Vacuum bag 700 x 1825 mm / 50 liter EUDAMED
Orfit GUDID
Generic name
Radiological whole-body positioner
Device name
Vacuum bag
Model / reference
18200/INDEX, Vacuum Bag Cushions
Primary DI / UDI-DI
05420028708484
Basic UDI-DI
5420028700314V
510(k) Number
FDA product code
IYE
EMDN code
Z11010180 Linear accelerators - hardware accessories
GMDN term
Radiological whole-body positioner
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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

Cleared under the same submission (K991319)

and 8 more cleared under K991319

Similar devices in this category

Other devices filed under LINEAR ACCELERATORS - HARDWARE ACCESSORIES.

Other devices from Orfit Industries NV

See all devices from Orfit Industries NV →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)