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Extron 3

by Drtech Corp.

Ref EXTRON 3

Extron 3 is a device classified as Class IIb in the EU and Class II in the US made by Drtech Corp., registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 88000184SCXXXXXXXX4P), cleared under FDA 510(k) K250010 on 10 Jun 2025 and listed in FDA GUDID since 17 Jun 2025 (UDI-DI 08800018422601), 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) K250010

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 Number88000184SCXXXXXXXX4P Basic UDI-DI 08800018422601UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800018422601 UDI-DI Date17 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK250010 Date10 Jun 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000184SCXXXXXXXX4P registered 23 Jul 2026 Active
  • FDA 510(k) K250010 decided 10 Jun 2025 Active
  • FDA GUDID UDI-DI 08800018422601 listed 17 Jun 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K250010
  2. Listed FDA GUDID 08800018422601
  3. Registered EUDAMED 88000184SCXXXXXXXX4P

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  • Withdrawn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
Mobile general-purpose fluoroscopic x-ray system, digital
Device name
Mobile Fluoroscopic X-ray System
Model / reference
EXTRON 3
Primary DI / UDI-DI
08800018422601
Basic UDI-DI
88000184SCXXXXXXXX4P
Direct marketing DI
08800018422601
510(k) Number
FDA product code
OXO, JAA, OWB
EMDN code
Z11039017 Mobile radioscopic units
GMDN term
Mobile general-purpose fluoroscopic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1650
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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

Similar devices in this category

Other devices filed under MOBILE RADIOSCOPIC UNITS.

Other devices from Drtech Corp.

See all devices from Drtech Corp. →

Properties

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