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Cruxcan Crx-1000

by CRUXELL Corp

Ref CRX-1000

Cruxcan Crx-1000 is a medical device (EU MDR Class IIa; FDA Class II; FDA product code MUH, System, X-Ray, Extraoral Source, Digital; EMDN category digital computed radiography (cr) systems - hardware accessories) made by CRUXELL Corp, registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI 88000496CX1C000SEX), cleared under FDA 510(k) K183637 on 12 Feb 2019 and listed in FDA GUDID since 15 Apr 2019 (UDI-DI 08800049600016), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183637

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 Number88000496CX1C000SEX Basic UDI-DI 08800049600016UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800049600016 UDI-DI Date15 Apr 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183637 Date12 Feb 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000496CX1C000SEX registered 10 Sep 2026 Active
  • FDA 510(k) K183637 decided 12 Feb 2019 Active
  • FDA GUDID UDI-DI 08800049600016 listed 15 Apr 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183637
  2. Listed FDA GUDID 08800049600016
  3. Registered EUDAMED 88000496CX1C000SEX

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  • Withdrawn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
Cruxcan
Generic name
Dental computed radiography digital imaging scanner
Device name
Dental PSP Scanner
Model / Ref / Catalog
CRX-1000
Primary DI / UDI-DI
08800049600016
Basic UDI-DI
88000496CX1C000SEX
Direct marketing DI
08800049600016
510(k) Number
FDA product code
MUH
EMDN code
Z11060280 Digital computed radiography (cr) systems - hardware accessories
GMDN term
Dental computed radiography digital imaging scanner
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.1800
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Dental computed radiography digital imaging scanner

Similar devices in this category

Other devices filed under DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - HARDWARE ACCESSORIES.

Other devices from CRUXELL Corp

  • Cruxcan (CRX-1000)

    Class II

  • Cruxview

    Class II

Properties

  • Single use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)