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Varex Imaging 18285-10

by Varex Imaging Nederland B.V.

Ref 18285-10Model SSMC SET 616, 1001

Varex Imaging 18285-10 is a medical device (EU MDD Class IIb; FDA Class I; FDA product code IZO, Generator, High-Voltage, X-Ray, Diagnostic; EMDN category radiology instruments) made by Varex Imaging Nederland B.V., registered in EUDAMED on 12 May 2026 (Basic UDI-DI B-08718755001303) and listed in FDA GUDID since 2 Sep 2019 (UDI-DI 08718755001303), active as of 23 Oct 2026.

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

CE MDD

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/MDD EUDAMED NumberB-08718755001303 Basic UDI-DI 08718755001303UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08718755001303 UDI-DI Date2 Sep 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08718755001303 registered 12 May 2026 Active
  • FDA GUDID UDI-DI 08718755001303 listed 2 Sep 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08718755001303
  2. Registered EUDAMED B-08718755001303

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Varex Imaging
Generic name
Solid-state-semiconductor radiation measuring probe
Device name
SolidStateMC series MDD
Model / reference
18285-10, SSMC SET 616, 1001
Primary DI / UDI-DI
08718755001303
Basic UDI-DI
B-08718755001303
FDA product code
IZO
EMDN code
Z11030599 Radiology instruments - other
GMDN term
Solid-state-semiconductor radiation measuring probe
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
892.1700
EU registration type
Legacy device (under a directive)
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 I

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Solid-state-semiconductor radiation measuring probeMultichannel radiation survey meter

Similar devices

Also classified as Multichannel radiation survey meter.

Similar devices in this category

Other devices filed under RADIOLOGY INSTRUMENTS - OTHER.

Other devices from Varex Imaging Nederland B.V.

See all devices from Varex Imaging Nederland B.V. →

Properties

  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)